FDA Adverse Event Injury Summary report: N

ELECTRIC DERMATOME HANDPIECE

MDR report key: 3223823 · Received July 10, 2013

Report

Report Number: 1526350-2013-00354
Event Type: Injury
Date Received: July 10, 2013
Date of Event: June 11, 2013
Report Date: June 11, 2013
Manufacturer: ZIMMER SURGICAL
Product Code: GFD
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 03/02/1999 AND WAS LAST REPAIRED ON 04/15/2013 FOR PREVENTATIVE MAINTENANCE. EVAL OF THE DEVICE OBSERVED THAT THE CONTROL BAR WAS SLIGHTLY BEHIND THE MASTER BLADE. THE MOTOR OF THE DEVICE WAS OBSERVED TO OPERATE ERRATICALLY AND OUT OF SPECS. CALIBRATION OF THE DEVICE WAS DETERMINED TO BE OUT OF SPECS AT THE ZERO THICKNESS SETTING ON THE LEFT AND RIGHT SIDE. THE DEVICE WAS ALSO OUT OF CALIBRATION AT THE SIDE TO SIDE SPECS. IMPROPER HANDLING BY THE USER MOST LIKELY CAUSED THE DAMAGE TO THE DEVICE, LACK OF CALIBRATION AND THE MOTOR OPERATING OUT OF SPEC. THE DEVICE WAS RECEIVED AND RETURNED TO THE CUSTOMER.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ZIMMER ELECTRIC DERMATOME WAS CUTTING UNEVENLY AND "MAKING BITES". ADD'L CLINICAL F/U WITH THE HOSPITAL INDICATED THAT THE HARVESTED GRAFT WAS ABLE TO BE USED AND NO ADD'L UNPLANNED GRAFT HARVESTS WERE REQUIRED. IT WAS REPORTED THAT WHEN THE USER EXPERIENCED THE ISSUE, THEY SWITCHED OUT THE REPORTED DEVICE FOR AN ALTERNATE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO EXTENSION IN SURGICAL TIME AND THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REQUIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
316203	ELECTRIC DERMATOME HANDPIECE	ELECTRIC DERMATOME HANDPIECE	GFD	ZIMMER SURGICAL	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1