BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 1960739 · Received December 16, 2010

    Report

    Report Number
    1811755-2010-02041
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER COMMENT WAS CONFIRMED. THE DEVICE HAD NUMEROUS DENTS AND MARKINGS CONSISTENT WITH ROUGH HANDLING. IF THE BLADE MOUNT BECOMES DAMAGED TO THE POINT OF BENDING OR DEFORMING, THEN BLADE WILL BIND AND CAUSE A SITUATION OF ADDED FRICTION HEAT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE MAINTENANCE VISIT AT A CUSTOMER, THE FIELD SERVICE TECH INDICATED THAT THE HANDPIECE GETS HOT AFTER 40 SECONDS RUN TIME. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL SAW ATTACHMENT SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK