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

Model Number	N/A
Medical Device Problem Codes	Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).No product was returned; functional and dimensional evaluations could not be performed.Visual evaluation of the provided pictures found the carrier was bent and warped near the edges, which could affected functional performance.The reported event and product identification could not be confirmed through visual evaluation.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 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.E1 telephone number: (b)(6).G2 country: australia.
Event or Problem Description
It was reported that during surgery the product was breaking the skin graft and there is an elevation on the smooth side of the carrier.An alternative carrier was used to complete the procedure and an unplanned additional skin graft was taken.There was no further patient impact or delay noted.Due diligence is complete and there is no additional information 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: 18986207
• Report Number: 0001526350-2024-00385
• Device Sequence Number: 8265497
• Product Code: FZW
• UDI-Device Identifier: 00889024375482
• UDI-Public: (01)00889024375482(17)270817(10)65591974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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 Model Number: N/A
• Device Catalogue Number: 00770800010
• Device Lot Number: 65591974
• 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: 03/13/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN MESHER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose