BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO QUICK COUPLING F/DRILL BITS

    MDR report key: 4221902 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14413
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. THE DEVICE MANUFACTURE DATE IS UNKNOWN. THE 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 MOST LIKELY DUE TO VARIOUS WORN COMPONENTS AND BEARINGS DETERIORATION FROM NORMAL WEAR OUT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE QUICK COUPLING DEVICE WOULD NOT HOLD THE GAUGE OR DRILL BIT. IT WAS FURTHER REPORTED THAT THE CARRIER SHAFT COUPLING WAS DENTED. 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
    701231 AO QUICK COUPLING F/DRILL BITS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 5718

    Patients

    Seq Age Sex Outcome Treatment
    1 GAUGE| DRILL BITS DEVICE