MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. MESHGRAFT II COMPLETE; EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00219500000
Medical Device Problem Codes	Failure to Cut (2587); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Laceration(s) (1946); Graft failure (4905)
Date of Event	10/22/2024
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: finland.
Event or Problem Description
It was reported that during surgery, the unit was not working properly, it cut holes only half of the graft.The taken graft was damaged, but it was usable.An additional unplanned skin graft was needed in order to complete the surgery, and it was taken from the same site.There was no surgical delay reported, and no sutures were needed.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, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h11.Review of the most recent repair record determined the device failed the sample mesh test during evaluation; the cutter was damaged and the device was out of calibration.The cutter was replaced and the device was recalibrated and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to component failure as the device exhibits wear and tear from repeated use.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 is no additional information regarding the event.

• Brand Name: MESHGRAFT II COMPLETE
• 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: 21207680
• Report Number: 0001526350-2025-00071
• Device Sequence Number: 8071666
• Product Code: FZW
• UDI-Device Identifier: 00889024372528
• UDI-Public: (01)00889024372528(11)211124(10)65347494
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 07/30/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00219500000
• Device Lot Number: 65347494
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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