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

Catalog Number	00219500000
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Failure to Advance (2524); Failure to Cut (2587)
Health Effect - Clinical Codes	Insufficient Information (4580); Graft failure (4905)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown time the mesher doesn¿t cut through in all places.It ¿chews¿ when it¿s supposed to drive the plate forward, and sometimes it doesn¿t grab the plate at all.It feels loose according to the doctor.Patient impact is unknown.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in sweden.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.
Event or Problem Description
It was reported that during surgery the mesher doesn¿t cut through in all places.It ¿chews¿ when it¿s supposed to drive the plate forward, and sometimes it doesn¿t grab the plate at all.It feels loose according to the doctor.The graft was used but not fully expanded as planned.There was no harm.There was a minimal delay.The graft was partly damaged and not completely meshed.No additional graft was needed, and no sutures were needed.This was a single event.Due diligence is complete as multiple attempts were made; however, no further information is available.As no additional information is available, we are unable to provide further information.

• 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: 23741677
• Report Number: 0001526350-2025-01546
• Device Sequence Number: 8460569
• Product Code: FZW
• UDI-Device Identifier: 00889024372528
• UDI-Public: (01)00889024372528(11)170517(10)63676633
• Combination Product (Y/N): N
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 00219500000
• Device Lot Number: 63676633
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 06/12/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/16/2025; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2017
• 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
• Patient Sex: Unknown