BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER PERFORMANCE SERIES SAW BLADE

    MDR report key: 18173732 · Received November 17, 2023

    Report

    Report Number
    MW5148305
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 25, 1965
    Report Date
    November 3, 2023
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STRYKER PERFORMANCE SERIES SAW BLADE REF# 6118-127-100 HAS HOOKS THAT HOLD THE SAW BLADE INTO THE SAW. DURING USE, THE HOOKS BROKE OFF. AN ADDITIONAL SAW BLADE HAD TO BE UTILIZED TO COMPLETE THE PROCEDURE. STRYKER REP WAS NOTIFIED AND IS IN CONTACT WITH STRYKER MARKETING AND ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069379 STRYKER PERFORMANCE SERIES SAW BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS 6118-127-100 23102017

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention