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

Catalog Number	00880100100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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 an unknown time in january 2025, the device was in need of repair for an unknown reason.During product evaluation, it was found that the 4 in.And 1 in.Width plates were damaged.There was no patient harm/injury reported.Due diligence is complete; no further information is available.There was no adverse event associated with this malfunction.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet (b)(4).Review of the most recent repair record determined the swivel was loose.The ball bearings were worn.The 4 in.And 1 in.Width plates were damaged.The fine adjustment cams needed replaced.The swivel, planetary carrier assembly, motor, fine adjustment cams, nut bearing lock, 4 in.And 1 in.Widthplates were replaced.New vespels and semi-circles were installed and resolved the reported issue.It was noted that the device was last serviced in 2021 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.The reported event was not 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.

• 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: 24954791
• Report Number: 0001526350-2026-00483
• Device Sequence Number: 12114130
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• UDI-Public: (01)00889024375901(11)200827(10)64874532
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: 64874532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• 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: 04/16/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• 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