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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problem Localized Skin Lesion (4542)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during surgery the device was unable to perform an initial cut (irregular cutting).There was a delay of 30 minutes of which the patient was under anesthesia, and an additional graft was taken.

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 the control bar was not in the correct position, calibration out, and the thickness control lever was replaced due to the ball detent not being in the correct position and the control bar was placed in the correct position and spring seal stretched and bearings replaced and resolved 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: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11693005
• MDR Text Key: 246600693
• Report Number: 0001526350-2021-00460
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 64643576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1