BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3895080 · Received June 25, 2014

    Report

    Report Number
    0001811755-2014-02268
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, SAFETY PIN FRACTURE, WAS CONFIRMED. THROUGH VISUAL AND FUNCTIONAL INSPECTION, THE TECHNICIAN FOUND THAT THE SAFETY PIN WAS BROKEN OFF, TECHNICIAN IDENTIFIED WORN FRONT CAP. THE FRONT CAP, SAFETY PIN, BLADE MOUNT ASSEMBLY, AND OTHER SUGGESTED PARTS WERE REPLACED AND THE HANDPIECE WAS RETURNED TO THE CUSTOMER AFTER PASSING THE FINAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY PIN FROM SYSTEM 6 SAGITTAL SAW FELL DURING SERVICE AT THE MANUFACTURER FACILITY. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371221 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1