BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO/ASIF DRILL-ATTACHM F/EPD+APD

    MDR report key: 4033868 · Received August 25, 2014

    Report

    Report Number
    8030965-2014-00869
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    December 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INVESTIGATION REVEALED THE DEVICE REQUIRED PREVENTIVE AND CORRECTIVE MAINTENANCE. VARIOUS COMPONENTS WERE CLEANED, LUBRICATED AND REPLACED. MAINTENANCE WAS CONDUCTED AND TESTS PERFORMED BEFORE RETURNING DEVICE TO CUSTOMER ON (B)(4) 2012. THE COMPLAINT IS INDETERMINATE. (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ADAPTOR PRESENTED MALADJUSTMENT AND FAILURE TO CONNECT WITH SHAFT OF DRILLS, WHICH CAUSED OSCILLATION AND VIBRATION IN EQUIPMENT WHILE EXECUTING ACTIONS DURING PERFORMANCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512185 AO/ASIF DRILL-ATTACHM F/EPD+APD HWE SYNTHES GMBH 1586132

    Patients

    Seq Age Sex Outcome Treatment
    1