BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14CM ANGLE ATTACHMENT

    MDR report key: 4122316 · Received September 26, 2014

    Report

    Report Number
    1045834-2014-13090
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 19, 2013
    Report Date
    July 19, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WORN BEARINGS FROM NORMAL USE AND SERVICING OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE NETHERLANDS THAT UPON RECEIPT OF A NEWLY PURCHASED ATTACHMENT DEVICE AT THE HOSPITAL, IT WAS OBSERVED THAT IT LOOKED USED AND WORN; AND THAT THE DRIVER SHAFT SHOWED SIGNS OF WEAR. DURING IN-HOUSE ENGINEERING EVALUATION AT PRE-TESTING, IT WAS DISCOVERED THAT THE DEVICE WAS FOUND TO HAVE A HIGH TEMPERATURE. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601238 14CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1