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

Model Number	N/A
Medical Device Problem Codes	Failure to Cut (2587); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported during unknown timing, that the device does not proper mesh and the cutter blade was worn.No adverse event is associated with this malfunction.Due diligence is in process and there is no additional information available at this time.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under: (b)(4).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
It was reported that malfunction occurred during surgery.Another device was used to complete the surgery.There was no delay.The taken graft was damaged but another unplanned graft was not taken.Due diligence is complete and there is no additional information available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the device failed the test mesh during device evaluation.The cutter was replaced to resolve the reported issue.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 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
No additional details regarding the event are available.

• Brand Name: MESHGRAFT II INSTRUMENT ONLY
• 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: 16271224
• Report Number: 0001526350-2023-00111
• Device Sequence Number: 17650535
• Product Code: FZW
• UDI-Device Identifier: 00889024372535
• UDI-Public: (01)00889024372535(11)161213(10)63501525
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00219500100
• Device Lot Number: 63501525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/01/2023; 05/03/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 02/13/2023; 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2016
• 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
• Patient Sex: Unknown