MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. MESHGRAFT II INSTRUMENT ONLY; Expander, Surgical, Skin Graft

Catalog Number	00219500100
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Graft failure (4905)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown time the back-and-forth mechanism was defective.It damages the graft and does not allow it to be moved backward (the handle).Patient impact is unknown.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.
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in belgium.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.

• Brand Name: MESHGRAFT II INSTRUMENT 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: 23632430
• Report Number: 0001526350-2025-01498
• Device Sequence Number: 15787073
• Product Code: FZW
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 00219500100
• Device Lot Number: 64370998
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 06/10/2026; 09/29/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 06/10/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2019
• 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