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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Orthohelix Surgical Designs, Inc 07-Apr-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771




April 7, 2006

David B. Kay, MD
Chief Executive Officer
Orthohelix Surgical Designs, Inc .
1815 West Market Street, Suite 205
Akron, OH 44313

Dear Dr. Kay:

The Food and Drug Administration (FDA) conducted an inspection of your medical device manufacturing facility in Akron, OH from January 10-31, 2006 . Our Investigator documented serious deficiencies from the Correction and Removal Regulation, Title 21, Code of Federal Regulations (CFR), part 806 (21 CFR 806) and the Quality System Regulation (21 CFR 820) that cause the MaxLock™ Driver system to be misbranded and adulterated.

Your MaxLock™ Driver system is misbranded within the meaning of section 502(t)(2) of the Federal Food Drug and Cosmetic Act (the Act ) [21 U.S.C. 352(t)(2)] in that a report of correction or removal was not submitted to FDA as required by section 519(f)(1) of the Act [21 U.S .C. 360i(f)(1)]. The Correction and Removal Regulation (21 CFR 806), promulgated under section 519(f)(1), requires manufacturers and importers to promptly report to FDA, within 10 working days, any correction or removal of a device to reduce a risk to health. In November 2005, your firm initiated a field correction and removal related to reports that the pilot tip of the MaxLock™ Driver system was breaking. However, this was never reported to the FDA.

FDA has evaluated that action and classified the correction and removal as a Class II recall. A Class II designation indicates that exposure to the violative product may cause temporary adverse health consequences. See 21 CFR 7.3(m). FDA regulations require manufacturers and importers to promptly report to FDA any correction or removal of a device if the correction or removal was initiated to reduce a risk to health. See 21 CFR 806.10(a)(1). Because your firm's actions described above meet the definitions of "correction" and/or "removal" in 21 CFR 806.2 and because FDA has found that the correction or removal was initiated to reduce a risk to health, your failure to report the product removal until the issue was raised by our investigator violated 21 CFR 806.10(a)(1). Even if you believed you were not required to report the correction or removal to FDA, you did not have a written justification for not reporting this action to the FDA in violation of 21 CFR 806.20(b)(4).

The MaxLock™ Driver system is also adulterated within the meaning of section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the QSR (21 CFR 820). During the January 2006 inspection, our Investigator documented the following deviations, among others, from the QSR:

1. The design input requirements for the MaxLock™ System was incomplete and ambiguous. For example: the intended population not described, environment in which the product is intended to be used not characterized, interfaces with the instrumentation not detailed, human factors requirements not addressed, mechanical performance specifications not listed for the screws and plates, and no descriptive information regarding such specifications such as : radius edges, low profile, and non-locking screw/plate interface. [21 CFR 820.30(c)]

2. The design verification results, including identification of the design, methods, the date, and the individual performing the verification, were not documented and filed in the design history file. For example, there was no documentation of review and approval of the mechanical testing conducted on the MaxLock™ System. This mechanical testing was conducted by an outside test laboratory. The laboratory provided test results to the firm. There was no documentation that these results were reviewed, approved, or met their design specifications . [21 CFR 820.30(f)]

3. Procedures for validating the device design were not complete. Specifically, the Validation Plan for the MaxLock™ System dated 11/21/04 (Rev. A) did not define what size/shapes of plates/screws were being tested or how the implants were to be used (i .e.: hand or foot surgery). There is no documented rationale for why all implants were not tested, or if the ones selected represented the most challenging/worst case construct. [21 CFR 820.30(g)]

4. The results of design validation, including identification of the design, methods, the date, and the individual performing the validation, were not documented and filed in the design history file. Specifically, the validation data collected was summarized in meeting minutes dated 7/8/05. There was no raw data/feedback collected or maintained, the method of testing not defined, and the date the testing was conducted was not documented in the DHF. [21 CFR 820.30(g)]

5. Design verification did not confirm that the design output meets the design input requirements. For example there was no verification testing conducted to assure that all sizes/shapes of the MaxLock™ Systems would fit hand and/or foot bones. [21 CFR 820.30(f)]

We acknowledge your letter dated February 16, 2006 and signed by Lee A. Strnad, Senior Development Manager, responding to the FDA-483 Observations. Your response to Observation #1 of the FDA-483, regarding the correction or removal of the MaxLock™ Driver system, is inadequate. As noted above, the corrective action you took represents a class 11 recall that should have been reported to FDA. Please provide an updated response to this issue. Regarding FDA-483 Observation #5, (#3 above), you should provide a more detailed description of why you did not test all sizes of plates and screws.

The remainder of your proposed corrections appear to be adequate so long as they are properly implemented. We will not be able to verify the sufficiency of your response until the next inspection. In the meantime, please provide any updates, if applicable, on the status of the corrective actions you have taken.

The deficiencies listed above are serious violations of the law. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. Possible actions include, but are not limited to, seizure, injunction, and/or civil monetary penalties.

Neither this letter nor the FDA-483 that was issued at the conclusion of the inspection is intended to be an all-inclusive list of deficiencies at your facility. As CEO of Orthohelix Surgical Designs Inc., it is your responsibility to assure adherence to each requirement of the Act and regulations. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be system problems, you must promptly initiate permanent corrective actions.

Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the deviations listed above. In addition, please submit any additional documentation to show the corrections initiated in conformance with the requirements of the Quality System Regulation. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.

Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, no requests for Certifications to Foreign Governments will be approved until the violations related to the subject devices have been corrected.

Your written response to this Warning Letter should be sent to Mr. Stephen J. Rabe, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Mr. Rabe at (513) 679-2700, extension 163, or you may forward a facsimile to him at (513) 679-2773.



Carol A. Heppe
District Director
Cincinnati District