BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13.5CM ANGLE ATTACHMENT

    MDR report key: 4241699 · Received November 10, 2014

    Report

    Report Number
    1045834-2014-14889
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 29, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: THE CONTACT DID NOT PROVIDE A TELEPHONE NUMBER. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE OBSERVED THAT THE BEARINGS IN THE BACK END WERE WORN OUT, WHICH CAUSED HEAT. THEREFORE, AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WORN OUT BEARINGS FROM NORMAL WEAR AND SERVICING OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR SURGERY, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE HAD BEARING ISSUES. THE REPORTER STATED THAT THE USER COULD FEEL ¿THE INSTABILITY¿. IT WAS NOT REPORTED IF THERE WERE CAN DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    723620 13.5CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1