BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT

    MDR report key: 5823154 · Received July 26, 2016

    Report

    Report Number
    1045834-2016-12308
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Report Date
    July 7, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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 IMPROPER MAINTENANCE, WHICH IS USER ERROR/MISUSE/ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS HEATING UP AND THE TEMPERATURE WAS ABOVE SPECIFICATION. THE DEVICE ALSO FAILED THE TEMPERATURE PRE-TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS HEATING UP. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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
    476229 8CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1