BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL

    MDR report key: 5233840 · Received November 18, 2015

    Report

    Report Number
    3009450871-2015-14305
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Report Date
    November 9, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTERS PHONE NUMBER (B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE CONTROL UNIT WAS NOT FUNCTIONING. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS FURTHER DETERMINED THAT THE MACHINE HAD NO FUNCTION AND THE CONTROL UNIT WAS DEFECTIVE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT CONTROL UNIT ON THE BATTERY REAMER/DRILL DEVICE WAS NOT FUNCTIONING. IT WAS NOTED IN THE SERVICE ORDER THAT THE MACHINE HAD NO FUNCTION AND THE CONTROL UNIT WAS DEFECTIVE. 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
    763478 BATTERY REAMER/DRILL BATTERY, REPLACEMENT, RECHARGEABLE MOQ DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1