BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X90MM)

    MDR report key: 14523615 · Received May 27, 2022

    Report

    Report Number
    3015967359-2022-01070
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 27, 2022
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    GFA
    UDI-DI
    04546540501417
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PTG (PATELLER TENDON GRAFT) PROCEDURE, TWO BLADES BROKE IN THE PATIENT¿S KNEE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED USING A DIFFERENT BLADE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803618 PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X90MM) BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 6118127090 22036017 04546540501417

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown