BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT

    MDR report key: 4182746 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14644
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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 NOT RETURNED FOR EVALUATION. HOWEVER, THE CUSTOMER SENT PHOTOGRAPHIC PICTURES FOR EVALUATION. RELIABILITY ENGINEERING REVIEWED THE PHOTOGRAPHIC IMAGES AND DETERMINED THAT IT APPEARED THE ATTACHMENT DEVICE WAS NOT PROPERLY CLEANED, RESULTING IN A BUILDUP OF DEBRIS AROUND THE BALL BEARINGS. THIS DEBRIS COULD CAUSE FRICTION ON THE CUTTER WHILE IN USE, WEAKENING IT, AND ULTIMATELY SHEARING IT OFF. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO USER ERROR, MISUSE AND/ OR ABUSE. 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

    REPORT 6 OF 6 FOR THE SAME EVENT: IT WAS REPORTED FROM TAIWAN THAT DURING A CERVICAL SPINAL SURGICAL PROCEDURE, IT WAS DISCOVERED THAT WHEN THE SURGEON WAS USING THE ATTACHMENT DEVICE, THE END OF THE CUTTER BROKE AFTER 5 MINUTES OF USING TIME. THE REPORTER INDICATED THAT THE RESIDUAL PART OF THE CUTTER WAS STUCK IN THE ATTACHMENT DEVICE. ACCORDING TO THE REPORTER, THE DEVICE WAS BRAND NEW. THE REPORTER INDICATED THAT THE EVENT OCCURRED 5 TIMES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY 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
    660345 MINIMAL ACCESS ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT HBE DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 CUTTER DEVICE