BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP )

    MDR report key: 18886814 · Received March 12, 2024

    Report

    Report Number
    0001526350-2024-00326
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    September 12, 2023
    Report Date
    March 12, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS BY ZIMMER EVENT HAS BEEN RECORDED BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO AN INCOMPLETE CUT. THE CUTTER DOES NOT MEET THE ZIMMER MESH TEST ACCEPTANCE CRITERIA; HOWEVER, THE REPAIR WAS NOT COMPLETED BECAUSE CUTTERS ARE NOT REPAIRABLE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A DESIGN ISSUE. 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. ASSOCIATED REPORTS: 0001526350-2024-00324, 0001526350-2023-01309-1, 0001526350-2024-00327, 0001526350-2024-00328.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY ON, KEEPS (GRILL) TEARING THE SKIN GRAFT. DEVICE FAILED TEST CUT DURING EVALUATION. THERE WAS A PATIENT INVOLVED BUT NO HARM OR IMPACT REPORTED. DUE DILIGENCE INFORMATION COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721079 Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP ) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 61707935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose