BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT-DRIVE

    MDR report key: 4193607 · Received October 22, 2014

    Report

    Report Number
    8030965-2014-01589
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES 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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE COUPLING TOOL SIDE WAS WORN OUT. THIS WAS ATTRIBUTED TO FAULTY CARE AND MAINTENANCE. THE COMPUTER COMPONENTS WERE REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. MANUFACTURING DATE FOR THIS DEVICE IS UNAVAILABLE. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. DURING THE SERVICE TECHNICIAN FOUND THAT THE DRILL BIT WAS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671435 RADIOLUCENT-DRIVE HWE SYNTHES GMBH 6878

    Patients

    Seq Age Sex Outcome Treatment
    1