BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENTS PRECISION THIN

    MDR report key: 15028388 · Received July 14, 2022

    Report

    Report Number
    MW5110888
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 27, 2022
    Report Date
    June 30, 2022
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SAW BLADE HAD A SMALL BROKEN OFF PIECE AT THE TOP OF THE SAW BLADE THAT CONNECTS TO THE SAW ITSELF. REASON FOR USE: RIGHT TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057607 STRYKER INSTRUMENTS PRECISION THIN BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS 21338017

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male