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

Model Number N/A

Device Problems Failure to Cut (2587); Output Problem (3005)

Patient Problem Laceration(s) (1946)

Event Date 07/31/2020

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 the zimmer dermatome was skipping during usage and caused skip lesions resulting in sub optimal skin graft requiring an additional graft to be taken.There was no delay and the surgery was completed with a different device.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This medwatch is being filed to relay additional information.

Event Description

There is no additional information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.-review of the most recent repair record determined that the unit's rpm was erratic.The motor, plug harness, and switch were replaced and resolved the reported issue.-review of the device history record identified no deviations or anomalies during manufacturing.-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: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10419584
• MDR Text Key: 203292499
• Report Number: 0001526350-2020-00683
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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: 00882100100
• Device Lot Number: 62309681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 63