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

Catalog Number	88710100
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
Event or Problem Description
It was reported that during surgery, the zimmer dermatome was malfunctioning - two separate machines were opened and both were malfunctioning.This was not apparent at first - but when the first machine was used to harvest skin, it was clear that it was not smoothly taking skin, and in fact, it made a full thickness injury to the skin with a laceration all the way through dermis at the start of the graft harvest.Therefore skin graft harvest was immediately abandoned.As such, the wound was covered with btm cut to size and sewn in place with 4-0 monocryl.An additional surgery was required but was not completed at this institution.There was patient injury, and an unknown delay.The taken graft was damaged and became unusable.After the second machine sounded like the first the additional graft element was abandoned entirely.Due diligence is completed and there is no additional information available.
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, d4, d9.G1, g3, g6, h1, h2, h3, h4, h6, h11 review of the most recent repair records determined the reported event could not be confirmed however the control bar was loose which may have contributed to the reported event.The control bar was adjusted and resolved the reported issue.The device was manufactured in 2018 and has not since been returned for annual preventative maintenance.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported event is attributed to component failure as the device exhibits wear and tear from repeated use.Not able to confirm reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DERMATOME AN HANDPIECE
• Common Device Name: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24497581
• Report Number: 0001526350-2026-00243
• Device Sequence Number: 10115232
• Product Code: GFD
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 88710100
• Device Lot Number: 64246808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown