MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER® S.G. CARRIER 8 IN LENGTH (FOR USE WITH ZIMMER® SKIN GRAFT MESHER ONLY); EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00770800010
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Skin Tears (2516); Graft failure (4905)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).G2 foreign: united kingdom.Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that during surgery the carrier did not easily go through the mesher, causing the normal size and thickness skin graft to become caught in the roller.An alternate device was available to complete the procedure and an additional skin graft was required from the patient.No delay to the procedure was reported.Diligence is complete and there is no additional information.No additional consequences have been reported as a result of this malfunction.
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, d10, g1, g3, g6, h1, h2, h4, h6, h11.D10: concomitant therapy.Item#: 00770800010, zimmerâ® s.G.Carrier 8 in length, lot#: 79406246.Item#: unk, unknown skin graft mesher, serial#: unk, lot#: unk.No product was returned or pictures provided; functional, visual, and/or dimensional evaluations could not be performed.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
No additional information is available.

• Brand Name: ZIMMER® S.G. CARRIER 8 IN LENGTH (FOR USE WITH ZIMMER® SKIN GRAFT MESHER ONLY)
• 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: 21473029
• Report Number: 0001526350-2025-00258
• Device Sequence Number: 14365737
• Product Code: FZW
• UDI-Device Identifier: 00889024375482
• UDI-Public: (01)00889024375482(17)291020(10)79406246
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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?: Yes
• Device Catalogue Number: 00770800010
• Device Lot Number: 79406246
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown