MAUDE Adverse Event Report: Zimmer Surgical, Inc. HANDPIECE, ELECTRIC DERMATOME

Catalog Number	00882100100
Medical Device Problem Codes	Corroded (1131); Device Contamination with Chemical or Other Material (2944); 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 outside of surgery, the unit had a corroded motor, contaminated insulation and damaged part like plug harness assembly, worn screws and worn reciprocation arm.Inconsistent speed was confirmed after final investigation.There was no patient involvement.Due diligence is complete as no further information is 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 not stable, the screws and reciprocating arm were worn, the power cable was damaged (no exposed metal wiring), and the insulator was contaminated.The motor, reciprocating arm, screws, plug harness, and insulator were replaced to resolve the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to component failure as the device exhibits wear and tear from repeated use.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 for trends.G2: foreign - event occurred in france.

• Brand Name: HANDPIECE, ELECTRIC 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: 50820425
• Report Number: 0001526350-2026-01134
• Device Sequence Number: 21511059
• Product Code: GFD
• UDI-Device Identifier: 00889024375994
• UDI-Public: (01)00889024375994(11)170817(10)63733196
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 00882100100
• Device Lot Number: 63733196
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2026
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown