BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 4056435 · Received September 3, 2014

    Report

    Report Number
    2520274-2014-01104
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Report Date
    October 2, 2013
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINTS RELATED TO ISSUES WERE FOUND. POWER TOOL EVALUATION WAS COMPLETED ON DEVICE. THE REPORTER'S COMPLAINT THAT THE UNIT DOES NOT FUNCTION COULD NOT BE CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WASN'T DUPLICATED. HOWEVER IT WAS OBSERVED DURING PRE-REPAIR EVALUATION THAT THE DEVICE HAD HIGH TEMPERATURE AND VIBRATION. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SMALL BATTERY DRIVES (532.033) LOT D120808 WOULD NOT HOLD A CHARGE AND A SAGITTAL SAW ATTACHMENT (532.021 LOT 3947 IS FROZEN AND WILL NOT FUNCTION. THIS IS REPORT 1 OF 1 OF COMPLAINT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536917 SAGITTAL SAW ATTACHMENT HWE 3947

    Patients

    Seq Age Sex Outcome Treatment
    1