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

Catalog Number	00219500000
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
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./apinzon.G2 country: austria.
Event or Problem Description
It was reported that outside of surgery, the device was nonfunctional as it no longer cut the skin.There was no patient harm/injury or surgical delay as there was no patient involvement.Due diligence is in process, no further information is available.There was no adverse event associated with this malfunction.
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 before surgery, the device was nonfunctional as it no longer cut the skin.Blades are blunt.There was no patient harm/injury or surgical delay as there was no patient involvement.Due diligence is complete, no further information is available.There is no additional information regarding the event.
Event or Problem Description
There is no additional information regarding the event.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under: (b)(4).Review of the most recent repair record determined the device passed the test cut; however, the cutter was damaged.The cutter was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be 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: 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: 20426694
• Report Number: 0001526350-2024-01214
• Device Sequence Number: 18326830
• Product Code: FZW
• UDI-Device Identifier: 00889024372528
• UDI-Public: (01)00889024372528(11)160531(10)63369543
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 03/07/2025

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 Catalogue Number: 00219500000
• Device Lot Number: 63369543
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/13/2024; 03/05/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/16/2024; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CUTTER.PN, SN, AND LN: UNKNOWN.
• Patient Sex: Prefer Not To Disclose