MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME II HOSE: UK MA-7 SCHRADER, 3 M

Catalog Number	00885100206
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Skin Tears (2516)
Type of Reportable Event	Serious Injury
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 country: united kingdom.
Event or Problem Description
It was reported that during surgery, the device was set up in 8/10 as a graft thickness, but it was unable to harvest superficial skin graft.The pressure was low with the new hose, so they changed the hose and performed the surgery.The unit was not taking the graft evenly, the graft got stuck in the blade and the dermatome meshed a piece of the skin graft.The first graft was damaged and was regrafted in the first donor site.An additional unplanned skin graft was needed in order to complete the surgery.There was a surgical delay of 15-20 minutes, and the patient was under anesthesia during this delay.Another device was used to complete/finish the surgery.The surgical technique for the product was utilized.Due diligence is complete; no further information is available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, d4, g1, g3, g6, h1, h2, h4, h6, h10, and h11.Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be 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 is no additional information regarding the event.

• Brand Name: ZIMMER AIR DERMATOME II HOSE: UK MA-7 SCHRADER, 3 M
• 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: 22061439
• Report Number: 0001526350-2025-00656
• Device Sequence Number: 12881232
• Product Code: GFD
• UDI-Device Identifier: 00889024376144
• UDI-Public: (01)00889024376144(11)230405(10)66016269
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00885100206
• Device Lot Number: 81062229
• Was Device Available for Evaluation?: No
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown