Medical Device Safety Tips*
* Medical Device Safety Tips highlight what can go wrong if labeling is not followed, and provide advice on how to mitigate risks. Commonly known as Instruction for Use manuals or package inserts, labeling includes any written material from the manufacturer accompanying medical devices.
Air or Electric Dermatome Instruments
What is the problem?
FDA has received several reports of patients suffering lacerations when undergoing skin grafting procedures with air- or electric-powered Dermatome surgical instruments made by Zimmer, Inc. In one report, the device cut through to the bone and the original donor site had to be sutured. Zimmer found that in each case the devices were out of specifications or damaged because they had not been properly maintained.
How are these devices used?
Zimmer air- or electric-powered Dermatome instruments are used to harvest thin slices of skin from a donor site for grafting on another site.
What can I do to prevent patient injuries?
Proper maintenance is important for all medical devices. According to Zimmer, the Dermatome instrument should be returned every 12 months for inspection and preventive maintenance. Annual factory calibration checks are strongly recommended to verify continued accuracy.
How can I report problems to FDA?
If you suspect a problem with a medical device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities