MAUDE Adverse Event Report: Zimmer Surgical, Inc. ZIMMER AIR DERMATOME

Catalog Number	00880100100
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during kit inspection, the device's burns theatre handpiece not working, the device needed a new blades and new tin.After final assessment, inconsistent speed was confirmed.There was no note of patient impact or delay.Due diligence is completed and there is no additional information available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the motor speeds were unstable, the swivel was loose, the width plates, machined head, and spring pin were damaged, the screws and actuator were worn, and the neckpiece, retaining ring, and spring seal were corroded.The screws, machined head, spring pin, neckpiece, retaining ring, spring seal, reciprocating arm, swivel, motor, and sleeve were replaced to resolve the reported issue.The width plates were returned as is.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed 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 trends.G2: foreign - event occurred in united kingdom.

• 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 ; +1(574)526-0384
• MDR Report Key: 50099239
• Report Number: 0001526350-2026-00919
• Device Sequence Number: 18761765
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• UDI-Public: (01)00889024375901(11)160418(10)63339433
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 63339433
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/20/2025
• 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: 07/20/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown