BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER PRECISION THIN SAW BLADE

    MDR report key: 17692047 · Received September 5, 2023

    Report

    Report Number
    MW5145219
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 30, 2023
    Report Date
    August 31, 2023
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE SAWING BONE USING TPS SYSTEM AND SAW BLADE 2296-003-125, SAW BLADE BROKE WHERE PIECE CONNECTS INTO TPS HANDPIECE. STRYKER PRECISION THIN SAW BLADE 2296-003-125. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379978 STRYKER PRECISION THIN SAW BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Other