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

Catalog Number	88710100
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a dermatome was found damaged during service evaluation, including damaged width plates (1 inch, 3 inch, and 4 inch) and a worn reciprocation arm.The condition was identified during inspection, not during surgery.There was no patient involvement.Diligence is complete.
Additional Manufacturer Narrative
This incident is being recorded under (b)(4).G2: foreign - event occurred in united kingdom.E1: telephone- (b)(6).D10: unknown 1" widthplate serial number-unknown, unknown 3" widthplate serial number-unknown, unknown 4" widthplate serial number-unknown.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4 b5 d4 d9 g3 g6 h2 h3 h4 h6 h11 complaint can be confirmed through the returned product analysis.Review of the most recent repair record determined he reciprocating arm was worn and the width plate was damaged.The reciprocating arm was replaced to resolve the reported issue.The width plate was returned as is.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause has been identified as component failure as the device exhibits wear and tear from repeated use.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: 24428407
• Report Number: 0001526350-2026-00203
• Device Sequence Number: 8158818
• Product Code: GFD
• UDI-Device Identifier: 00889024464834
• UDI-Public: (01)00889024464834(11)230424(10)66016265
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 88710100
• Device Lot Number: 66016265
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown