MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 1.5 TO 1 DERMACARRIER; EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00219501200
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Graft failure (4905)
Date of Event	07/29/2025
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.
Event or Problem Description
It was reported that during surgery on, meshgraft was utilized with a 1.5:1 ratio dermacarrier and the graft was not useable after the pass through the meshgraft ii.Per the surgeon, the skin graft was damaged as it was turned into "spaghetti".It was unknown if there was surgical delay.An additional skin graft was needed to complete the surgery.Due diligence is complete; there is no additional information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, h10, and h11.No product was returned; functional and/or dimensional evaluations could not be performed.Visual evaluation of the provided pictures found no related issues.The dermacarrier was sealed within the sterile packaging.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 available.

• Brand Name: 1.5 TO 1 DERMACARRIER
• Common Device Name: EXPANDER, SURGICAL, SKIN GRAFT
• 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: 22872167
• Report Number: 0001526350-2025-01117
• Device Sequence Number: 5687746
• Product Code: FZW
• UDI-Device Identifier: 00889024372559
• UDI-Public: (01)00889024372559(17)300515(10)82330735
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 00219501200
• Device Lot Number: 82330735
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown