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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Failure to Cut (2587); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(6).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 that during surgery, the graft got stuck in the mesher during the procedure, the or disassembled the mesher to take it out.There was no patient harm/injury.There was no surgical delay.After taking 3 grafts from the patient, the first two grafts were sent through without a problem.The last graft was much longer and sending it through the first time missed a good chunk which was needed.The residents and surgeon decided to send just the missed chunk of tissue through the mesher but stopped before the already meshed tissue went through a second time.Resulting in the graft being "stuck" in the meshing device.They were then instructed by doctor to disassemble the device to release the graft which was needed to finish the surgery.They did not have the correct instruments to remove the screws from the device, but they did find that a few screw drivers from their sets did work.The one screw to remove the blades was difficult to release and tighten.They did not want to make it worse, so they put it back together as best they could and reported to their instruments specialist that it was "broken".Due diligence is in progress, there is no additional information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet 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 that the handle performed as intended.There was no unexpected intervention such as sutures were needed.An additional unplanned skin graft was not required to complete the surgery.The three grafts taken were a part of the normal procedure for this case.Due diligence is complete, there is no additional information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under cmp-(b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, and h10.Review of the most recent repair record determined the unit was out of calibration.The side plates were replaced and the unit was calibrated and resolved 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
There is no additional information available.

• 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: 17993317
• Report Number: 0001526350-2023-01377
• Device Sequence Number: 6754509
• Product Code: FZW
• UDI-Device Identifier: 00889024372528
• UDI-Public: (01)00889024372528(11)180320(10)63962203
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2024

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: 00219500000
• Device Lot Number: 63962203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 01/30/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/07/2023; 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2018
• 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: Prefer Not To Disclose