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

Model Number	N/A
Medical Device Problem Codes	Failure to Cut (2587); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abrasion (1689); Laceration(s) (1946)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the meshgraft ii was defective and needed to be repaired.The taken graft was damaged and an additional unplanned skin graft was needed.There was a surgical delay between 20 to 30 minutes due to the revision of skin grafts, and extension of damaged grafts using a cold blade scalpel.The patient was under anesthesia during the delay.There was no other patient harm/injury noted.Another device was used to complete the surgery.Due diligence is complete, no further information is available.
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: foreign: france.
Event or Problem Description
There is no additional information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the device passed the test mesh during device 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 a design issue.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.

• Brand Name: MESHGRAFT II COMPLETE
• Common Device Name: SKIN GRAFT MESHER
• 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: 17732838
• Report Number: 0001526350-2023-01125
• Device Sequence Number: 15062960
• Product Code: FZW
• UDI-Device Identifier: 00889024372528
• UDI-Public: (01)00889024372528(11)171024(10)63817573
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 00219500000
• Device Lot Number: 63817573
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2017
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Prefer Not To Disclose