BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    MDR report key: 3130628 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02334
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERRING TO DRAWING SE_108606 THE MISSING SETTING SCREW IS LOCKED WITH GLUE LOCTITE 243. BECAUSE OF THE MISSING COMPONENTS WE ARE NOT ABLE TO DETERMINE THE REASON FOR THIS EVENT. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A TIBIAL NAIL PROCEDURE ON (B)(6) 2013, THE FLEXIBLE SHAFT CONNECTOR FOR USE WITH THE JACOBS CHUCK BROKE AND FELL APART. THIS HAPPENED WHILE THE SURGEON WAS REAMING. THE PRODUCT WAS IMMEDIATELY SWAPPED OUT FOR A DIFFERENT DEVICE. THERE WAS NO DELAY OF SURGERY REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231534 FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK HTO SYNTHES GMBH 8053605

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR