BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.6CM TAPERED ATTACH, BM

    MDR report key: 3666774 · Received March 7, 2014

    Report

    Report Number
    1045834-2014-11592
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    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

    THIS DEVICE WAS RETURNED FOR SERVICE HOWEVER DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE NORMAL WEAR ON THE BEARINGS OVER TIME. 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 HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE (B)(4) EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE HAD "HIGH TEMPERATURE". THIS EVENT WAS 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
    140490 12.6CM TAPERED ATTACH, BM BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT GFF DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1