BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.5CM ANGLE ATTACHMENT

    MDR report key: 4151514 · Received October 8, 2014

    Report

    Report Number
    1045834-2014-13659
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 24, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. (B)(4) EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE FAILED THE CUTTER INSERTION ASSESSMENT. IT WAS DETERMINED THAT THE BEARINGS WERE WORN AND WERE NO LONGER IN AXIAL ALIGNMENT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE OF THE BEARINGS BEING OUT OF ALIGNMENT WAS DETERMINED TO BE NORMAL WEAR FROM USE AND SERVICING. 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 THE WHEN THE CUTTER DEVICE WAS INSERTED, THE ATTACHMENT DEVICE DID NOT SPIN. IT WAS NOT REPORTED THAT THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE 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
    633448 10.5CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1