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

Model Number	N/A
Medical Device Problem Codes	Failure to Cut (2587); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.Additional reports: 0001526350-2023-01119.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text: device not yet returned.
Event or Problem Description
It was reported that the account just received two 4:1 cutters and both cutters they tried on different meshers completely destroyed the graft.The event occurred during surgery on an unknown date.There was no reported patient harm, or delay.Due diligence is in progress, no further information is available at this time.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under cmp-(b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b1, b2, b3, b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h6 and h10 review of the most recent records found both cutters failed the test cut with an incomplete mesh.Review of the provided picture found the graft bunched on one side.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.Additional related reports: 0001526350-2023-01119-1.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 the account just received two 4:1 cutters and both cutters they tried on different meshers completed destroyed the graft.The event occurred during surgery.An additional unplanned skin graft was needed in order to complete the surgery.There was no excessive delay reported beyond the time to obtain a new device.Due diligence is complete, no further information is available at this time.

• Brand Name: Z.S.G.M. CUTTER 4:1 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: 17728296
• Report Number: 0001526350-2023-01120
• Device Sequence Number: 6440662
• Product Code: FZW
• UDI-Device Identifier: 00889024375475
• UDI-Public: (01)00889024375475(11)230519(10)66077513
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00770304000
• Device Lot Number: 66077513
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose