MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. Z.S.G.M. CUTTER 4:1 RATIO ( CAUTION: SHARP ); SKIN GRAFT MESHER

Catalog Number	00770304000
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
Event or Problem Description
It was reported that outside of surgery that the unit was functioning incorrectly.After evaluation of the returned product, it was determined that the cutter failed the test cut.There were no harm, injury or delay associated with the event.Due diligence is complete.No additional information is available.No adverse event reported.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under cmp(b)(4).Review of the most recent repair record identified the following related repair: the cutter failed the test cut with an incomplete cut.The cutter was returned to the customer without repair as they cannot be fully repaired without replacement.Review of the device history record identified no deviations or anomalies during manufacturing.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.Additional reports were generated mfr - 0001526350 - 2023 - 00981, mfr - 0001526350 - 2023 - 00982, mfr - 0001526350 - 2023 - 00983.

• Brand Name: Z.S.G.M. CUTTER 4:1 RATIO ( CAUTION: SHARP )
• 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: 17624000
• Report Number: 0001526350-2023-00984
• Device Sequence Number: 15339737
• Product Code: FZW
• UDI-Device Identifier: 00889024375475
• UDI-Public: (01)00889024375475(11)211028(10)65239258
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/25/2023

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 Catalogue Number: 00770304000
• Device Lot Number: 65239258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• 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: 08/21/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• 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: CATALOG #00770100000SERIAL # (B)(6)LOT # 64732110
• Patient Sex: Prefer Not To Disclose