MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP ); EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00770302000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The investigation is complete.This is an initial final report submission.Review of the most recent repair record determined the cutter failed the sample mesh test during evaluation due to an incomplete mesh.; however, the repair was not completed as cutters are not repairable devices.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
The device was sent in for preventative maintenance originally and found to be needing repaired.There was no patient involvement.Due diligence is complete, there is no additional information available.During device evaluation the cutter failed the sample mesh test due to an incomplete mesh.No adverse events were reported as a result of this malfunction.

• Brand Name: Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP )
• 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: 20916174
• Report Number: 0001526350-2024-01569
• Device Sequence Number: 8581652
• Product Code: FZW
• UDI-Device Identifier: 00889024375451
• UDI-Public: (01)00889024375451(11)200528(10)64732111
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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 Catalogue Number: 00770302000
• Device Lot Number: 64732111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• 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: 11/27/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2020
• 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: Prefer Not To Disclose