BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0 CM LONG ATTACHMENT

    MDR report key: 3123994 · Received May 22, 2013

    Report

    Report Number
    1045834-2013-02165
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 22, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT DEVICE WAS RECEIVED FOR EVALUATION. THE ATTACHMENT DEVICE WAS TESTED AND THE DEVICE HAS WORN/DAMAGED BEARINGS. EVIDENCE INDICATED THIS WAS DUE TO USAGE WEAR OVER TIME. THE REPORTED CONDITION WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA REGARDING AN ATTACHMENT DEVICE IN WHICH, DURING INSPECTION/TESTING, IT WAS OBSERVED THAT THE DEVICE WAS MAKING A "LOUD NOISE". THE ATTACHMENT DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225782 11.0 CM LONG ATTACHMENT MOTOR, DRILL, ELECTRIC- ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1