BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.2CM ATTACHMENT, BLACK MAX

    MDR report key: 3580679 · Received January 17, 2014

    Report

    Report Number
    1045834-2014-11148
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    PK974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. (B)(4) EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE NORMAL WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING ENGINEERING EVALUATION, THE ATTACHMENT DEVICE WAS TESTED AND FOUND THE TEMPERATURE WAS ABOVE SPECIFICATION. THE EVALUATION OCCURRED IN ENGINEERING EVALUATION; THIS EVENT IS NOT RELATED TO SURGERY. 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
    44950 8.2CM ATTACHMENT, BLACK MAX BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT GFF DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1