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

Catalog Number	00880100100
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Insufficient Information (4580); Graft failure (4905)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
There was no additional information associated with this event.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b1, b4, b5, e1, e2, e3, g2, g3, g6, h2, h6 and h11.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.
Event or Problem Description
It was reported that during surgery, the unit was skipping including width plates, screwdriver and hose.It was confirmed that the graft taken was damaged so another dermatome was used to complete the surgery.No sutures were required.A delay of an unknown amount of time occurred while the patient was under anesthesia.No sutures were required.Due diligence is complete.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b1, b2, b3, b4, b5, g3, g6, h1, h2, h6 and h11.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.
Event or Problem Description
It was reported that during an unknown time, the unit was skipping.It is unknown if there was patient impact or delay.Due diligence is in progress.
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2: canada.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record identified the following related repair: the control bar was loose and was adjusted to resolve the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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 for trends.
Event or Problem Description
There was no additional information associated with this event.

• 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: 23531961
• Report Number: 0001526350-2025-01431
• Device Sequence Number: 9083950
• Product Code: GFD
• UDI-Device Identifier: 00889024466012
• UDI-Public: (01)00889024466012(11)250221
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 67198241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 12/09/2025; 04/21/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/09/2025; 12/18/2025; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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: HOSE.IN: UNK.LN: UNK.; SCREW.IN: UNK.LN: UNK.; WIDTH PLATES.IN: UNK.LN: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown