BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DL MOTOR PREASSMBL

    MDR report key: 3120171 · Received May 20, 2013

    Report

    Report Number
    8030965-2013-02292
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE 510K #: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THE INTERNAL TURBINE OF AIR PEN DRIVE PRESENTS INTERMITTENT PERFORMANCE AND THERE IS EVIDENCE OF RESIDUE ON THE INTERNAL PART. IN ADDITION THE DEVICE WAS NOTED TO HAVE LOW REVOLUTIONS AND LOSS OF STRENGTH. IT WAS REPORTED THE REPLACEMENT PART WAS INSTALLED ON (B)(6) 2013. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222513 DL MOTOR PREASSMBL HWE SYNTHES GMBH SER. NO. 3891

    Patients

    Seq Age Sex Outcome Treatment
    1