BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLEAIRHOSE F/MINI AIR DRILL NO. 512.1

    MDR report key: 3242383 · Received July 23, 2013

    Report

    Report Number
    8030965-2013-04408
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 1, 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 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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION AND PERFORMANCE TEST HAVE CONFIRMED THAT THE INNER TUBE IS PULLED DOWN AND THEREBY THE HOSE IS LEAKING. THE REVIEW ON THE MATERIAL AND MANUFACTURING DOCUMENTS HAS SHOWN THAT THE DOUBLE TUBE HAS BEEN MADE IN ACCORDANCE WITH THE SPECIFICATIONS. THIS ALSO ENSURES THAT THESE PRODUCTS HAD UNDERGONE A 100% FUNCTION CHECK BEFORE THEY LEFT THE FACTORY. IT CAN NOT BE REPRODUCED WHICH CIRCUMSTANCES HAVE CAUSED THIS EVENT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE AIR HOSE WAS LEAKING DURING A PROCEDURE ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344186 DOUBLEAIRHOSE F/MINI AIR DRILL NO. 512.1 HWE SYNTHES GMBH 13598

    Patients

    Seq Age Sex Outcome Treatment
    1