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

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)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the mesher where the handle is being placed is broken/munted.It seems that the handle was forced to put on the side tip when used in theatre resulting the handle difficult to be taken off off.During the product investigation it was determined that the cutter failed the test cut.There were no reported harm/injury to patient or user neither were there any reported delay.Due diligence is complete.No adverse event reported.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the cutter failed the sample test cut.The cutter does not meet the zimmer mesh test acceptance criteria; however, the repair was not completed because cutters are not repairable devices.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.G2: country event occurred in is new zealand.

• Brand Name: Z.S.G.M. CUTTER 2:1 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: 17482557
• Report Number: 0001526350-2023-00887
• Device Sequence Number: 18368240
• Product Code: FZW
• UDI-Device Identifier: 00889024375451
• UDI-Public: (01)00889024375451(11)180620(10)64063547
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2023

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: 00770302000
• Device Lot Number: 64063547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• 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: 08/08/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2018
• 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