BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR-ATTACHM L F/EPD+APD

    MDR report key: 4071452 · Received September 9, 2014

    Report

    Report Number
    8030965-2014-00814
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Report Date
    July 31, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE BEARINGS JAMMED AND RUSTED, AND THE DEVICE OVERHEATED. THIS WAS ATTRIBUTED TO FAULTY CARE AND MAINTENANCE. MAINTENANCE WAS PERFORMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, TECHNICIAN NOTED THERE WAS OVERHEATING AND THE MOTOR WAS ROUGH. ALSO NOTED, WAS THE DEVICE WAS RUSTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553782 BURR-ATTACHM L F/EPD+APD HWE SYNTHES GMBH 1244869

    Patients

    Seq Age Sex Outcome Treatment
    1