MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

Catalog Number	00880100100
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being recorded under (b)(4).E1: telephone: (b)(6).G2: foreign: australia.Once investigation is complete a supplemental/final report will be submitted.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during surgery the device was not cutting properly.It is unknown if there was any patient impact or surgical delay.Diligence is complete as no additional information was noted.
Event or Problem Description
No additional event information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information related to final investigation results.The following sections were updated: b4 b5; d4; d9; g3; g6; h2; h3; h4; h6; h11 the reported event could not be confirmed.Review of the most recent repair record identified no repairs related to the reported event.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.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: ZIMMER AIR DERMATOME
• 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: 24925298
• Report Number: 0001526350-2026-00464
• Device Sequence Number: 9266850
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 00880100100
• Device Lot Number: 65071181
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2026
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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
• Patient Sex: Unknown