BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )

    MDR report key: 17299760 · Received July 11, 2023

    Report

    Report Number
    0001526350-2023-00676
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    February 14, 2023
    Report Date
    July 11, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024375444
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED AS AN INITIAL / FINAL REPORT BASED ON INFORMATION DISCOVERED DURING THE DEVICE EVALUATION. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE CUTTER FAILED THE TEST CUT WITH AN INCOMPLETE MESH. THE GEARS AND COLLARS WERE REPLACED; HOWEVER, THE CUTTER CANNOT BE FULLY REPAIRED WITHOUT REPLACEMENT. THE CUTTER WAS RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED. RELATED REPORTS: 0001526350-2023-00266-1, 0001526350-2023-00675. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE PRODUCED AN INCOMPLETE MESH. THERE WAS NO REPORTED PATIENT INVOLVEMENT, HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, EVALUATION FOUND THE CUTTERS ALSO FAILED THE TEST CUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193712 Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 65154555 00889024375444

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose