BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR

    MDR report key: 3240818 · Received July 22, 2013

    Report

    Report Number
    8030965-2013-04371
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE CARRIED OUT FUNCTIONAL TEST COULD NOT IDENTIFY ANY DEVIATION TO THE SPECIFICATIONS. THE CHUCK IS FULLY FUNCTIONAL. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON EXPERIENCED DIFFICULTY WITH USE OF THE JACOBS CHUCK. LUBRICATING THE DEVICE DID NOT RESOLVE THE ISSUE. THE DEVICE IS FAIRLY NEW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341301 CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR HWE SYNTHES GMBH 8141837

    Patients

    Seq Age Sex Outcome Treatment
    1