MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problems Abrasion (1689); Scarring (2061)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported that a dermatome malfunction occurred in which it was not cutting properly.The event occurred during surgery.According to dr.Van brussel the patient experienced a full thickness cut, scar wounds, and had to be stitched.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the control bar was out of position and the unit was out of calibration at the 0, 4, and 12 readings.The vespel and semi-circle bearings were replaced to tighten the torque on the thickness control lever.Additionally, the control bar was placed in the correct position and the device was calibrated to resolve the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

There is no additional information.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10884757
• MDR Text Key: 217666831
• Report Number: 0001526350-2020-00980
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 88710100
• Device Lot Number: 64371029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other