BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APD 60.000 RPM

    MDR report key: 4162061 · Received October 10, 2014

    Report

    Report Number
    8030965-2014-01549
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    May 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HBB
    PMA / PMN Number
    K093361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, IT WAS REVEALED THAT THE TRIGGER WAS JAMMED. THIS WAS ATTRIBUTED TO FAULTY HANDLING. THE DEVICE WAS REWORKED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    THE AIR PEN DRIVE WAS RETURNED FOR SERVICE ALONG WITH THE HAND SWITCH BECAUSE THE MOTOR WOULD NOT STOP RUNNING WHEN THE TRIGGER IS RELEASED. A STRANGE NOISE WAS ALSO REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643337 APD 60.000 RPM HBB SYNTHES GMBH 2123

    Patients

    Seq Age Sex Outcome Treatment
    1