BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING BLADE HEAVY DUTY

    MDR report key: 21834345 · Received April 14, 2025

    Report

    Report Number
    MW5168995
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    April 7, 2025
    Report Date
    April 8, 2025
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SAW BLADE IS BROKEN OFF IN THE FIELD AND A PIECE OF SAW WAS STUCK IN RECIPROCATING SAW. RECIP SAW WAS TAG. OBTAINED NEW RECIP SAW AND OPENED NEW SAW BLADE. BROKEN SAW BLADE RETRIEVED FROM THE STERILE FIELD AND KEPT FOR REFERENCE. CLINICIAN INFORMED. NO PIECES OF SAW WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270327 RECIPROCATING BLADE HEAVY DUTY BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS 0277-096-326

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other