Inspections, Compliance, Enforcement, and Criminal Investigations
Extremity Medical, LLC 2/24/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Waterview Corporate Center|
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4911
February 24, 2012
VIA UNITED PARCEL SERVICE
Mr. Jamy R. Gannoe
Extremity Medical, LLC
300 lnterpace Pkwy, Ste 410, Building A
Parsippany, New Jersey 07054-1148
Dear Mr. Gannoe:
During an inspection of your firm located in Parsippany, New Jersey, on September 28, 2011, through October 24, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures several orthopedic devices for the distal extremities. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that the devices are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under Section 519 of the Act, 21 U.S.C.§ 360i, and 21 CFR Part 803 - Medical Device Reporting. Your firm's response to the Form FDA 483 (FDA 483) dated November 24, 2011, was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The response may be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example, Product Experience Report (PER) #11-007 refers to an osteotomy procedure performed because of patient non-union. The device may have caused or contributed to a serious injury that resulted in an osteotomy. Extremity Medical did not submit a report regarding this incident to FDA.
Failure to submit a report to FDA no later than 30 calendar days after the day that, your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and that this device, or similar devices that your firm markets, would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example, PER #11-074 refers to a broken lag screw at the joint of a Hallux device. If the device breaks after implantation, as described in PER #11-074, and there is no revision surgery, then the malfunction may result in non-union of the patient's joint. The malfunction of a long-term implant is a reportable event per Comment 12 of the 1995 Final Rule for Medical Device Reporting. Extremity Medical did not submit a report to FDA.
Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example:
1. SOP-016, "Procedure for Product Surveillance," Rev. G, does not establish internal systems that provide for a standardized review process or procedure for determining when an event meets the criteria for reporting under 21 CFR Part 803. Specifically:
a. SOP-016 does not include adequate definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions, based on 21 CFR 803.3, of the terms "become aware," "caused or contributed," "malfunction," "MDR reportable event," and "serious injury," and definitions of the terms "reasonably known," and "reasonably suggests," found respectively in 21 CFR 803.50(b) and 803.20(c)(1).
b. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
2. SOP-016 does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically:
a. Section 7.1.1 of SOP-016 states, "Reporting time frames begin at the time when an Extremity Medical representative becomes aware of a complaint and has determined it as MDR/MDVR reportable event." SOP-016 does not clarify whether an Extremity Medical representative refers to any Extremity Medical employee. Please note that, per 21 CFR 803.3, your firm is considered to have become aware of an event when any employee becomes aware of a reportable event that is required to be reported within the timeframes specified in 21 CFR Part 803.
b. SOP-016 does not include the mailing address for submissions of MDRs to FDA. A manufacturer must submit any written reports or additional information to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002 as required by 21 CFR Part 803.12(a).
3. SOP-016 does not adequately establish documentation and record-keeping requirements. For example, SOP-016 does not require documentation of:
a. Information that was evaluated to determine if an event was reportable;
b. All medical device reports and information submitted to FDA; and
c. Systems that permit any authorized FDA employee to access records.
Our inspection also revealed that the IO Fix lntraOsseous Fixation Lag Screws and X-Posts are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806-Medical Devices; Reports of Corrections and Removals. These violations include, but are not limited to, the following:
Failure to submit a written report to FDA of any correction or removal of a device that was initiated to reduce a risk to health posed by the device, as required by 21 CFR 806.10(a). For example, on April 22, 2011, and April 25, 2011, your firm distributed a new revision of the "Surgical Technique and Quick Reference Technique Guide" for the IO Fix Intra Osseous Fixation device and notified distributers of the revised surgical technique. According to CAPA #10-024 and CAPA #10-026, the revisions to the surgical technique were initiated in response to the following PERs:
1. PER-10-040 and PER-10-041, both describing a lag screw pushing through the eyelet of the X-Post during separate surgeries; and
2. PER-10-043, describing a failure of the 6.6 post reamer, which resulted in a portion of the post reamer being left in the patient.
The distribution of the revised surgical technique was initiated to reduce a risk to health posed by the device because the events described in PER-10-040, PER-10-041, and PER-10-043 constitute a risk to health.
Our inspection also revealed that the Hallux lntramadullary Fusion Devices and IO Fix lntraosseous Fixation Lag Screws and X-Posts are adulterated under Section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under Section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under' Section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by Section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by Section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Specifically, your firm modified the screw lengths and locking angle configurations of the devices cleared in K082934 and K091577 (for the Hallux devices) and K101700 (for the IO Fix devices). Modifying a screw's design from a solid design to a cannulated design constitutes a change in the device that could significantly affect the safety or effectiveness of the device. Therefore these changes require a new premarket notification submission, as required by 21 CFR Part 807.81(a)(3)(i).
Please note that SOP-016, "Procedure for Product Surveillance.'' Rev. G, includes references to Baseline Reports. Baseline Reports are no longer required. It is recommended that all references to a Baseline Report be removed from your firm's MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
In addition, FDA has noted nonconformances with regards to Section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm's quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1. Failure to adequately inspect, test, or otherwise verify incoming product as conforming to specified requirements, as required by 21 CFR 820.80(b).
For example, the Inspection Guide Sheet for 3.0 mm Compression Screw, Part No. 101-30030, Lot JP1331, indicates that 8 out of 26 screws were inspected, 1 out of 8 screws was found having an undersized dimension and rejected, and the remaining 25 screws, including 18 screws that were not inspected for dimensions, were released without any additional inspection. The Inspection Guide Sheet indicates that a sample size of 8 was used based on an AQL of 2.5. For an AQL of 2.5 and a sample size of 8, the acceptable reject limit is 0. Therefore, the lot should not have been released without additional inspection.
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, SOP-016 "Procedure for Product Surveillance," Rev G, does not require that any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications be investigated, as required by 21 CFR 820.198(c).
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the awarding of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for ·the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response to this letter should be sent to: U.S. Food and Drug Administration, 10 Waterview Blvd, 3rd Floor, Parsippany, New Jersey 07054. Refer to the Unique Identification Number (CMS #255914) when replying. If you have any questions about the contents of this letter, please contact Stephanie Durso, Compliance Officer, at 973-331-4911 (phone) or 973-331-4969 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the lnspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
New Jersey District