MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. Z.S.G.M. CUTTER 3:1 RATIO ( CAUTION: SHARP ); EXPANDER, SURGICAL, SKIN GRAFT

Model Number	N/A
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 during surgery the device was not functioning properly.There was no harm or delay reported.Due diligence is complete.No additional event information available.At product evaluation investigation the cutter failed the test cut with an incomplete cut.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01272, 0001526350-2023-01273.The investigation is complete.This is an initial final report submission.Review of the most recent repair record determined the cutter failed the test cut with an incomplete cut.Cutters required replacement for full repair.The cutter was returned to the customer as is.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.

• Brand Name: Z.S.G.M. CUTTER 3:1 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: 17876358
• Report Number: 0001526350-2023-01274
• Device Sequence Number: 17239817
• Product Code: FZW
• UDI-Device Identifier: 00889024375468
• UDI-Public: (01)00889024375468(11)181101(10)64216174
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/05/2023

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: 00770303000
• Device Lot Number: 64216174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• 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: 10/04/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUTTER 1.5:1 RATIO.PN 00770301500SN (B)(6).
• Patient Sex: Prefer Not To Disclose