BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17479980 · Received August 8, 2023

    Report

    Report Number
    0001526350-2023-00881
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    March 2, 2023
    Report Date
    August 8, 2023
    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
    VA, 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 IDENTIFIED THE FOLLOWING RELATED FINDING: TECH FOUND THAT THE CUTTER DID NOT PASS THE SAMPLE MESH TEST. TECH REPLACED THE GEARS AND BEARINGS; HOWEVER, CUTTERS CANNOT BE FULLY REPAIRED WITHOUT REPLACEMENT. 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 REPORTS: 0001526350-2023-00318-1. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT IS NOT MESHING THROUGH TISSUE OCCURRED. THE EVENT OCCURRED DURING PROCESSING. THERE WAS NO REPORTED PATIENT HARM, OR PROCEDURAL DELAY. DEVICE EVALUATION DISCOVERED THE CUTTER ALSO FAILED THE SAMPLE MESH TEST CUT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796774 Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 62836096

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose