BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    MDR report key: 3042718 · Received April 9, 2013

    Report

    Report Number
    8030965-2013-01504
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE DEVICE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS IN SINGLE PARTS WHEN RECEIVED. THE SETTING SCREW WHICH HOLDS THE DEVICE TOGETHER AND THE RETAINING SPRING ARE MISSING. THE HOLDING SHAFT OF THE DEVICE SHOWS MARKS OF FORCIBLE USE. (B)(4). THE MICROSCOPIC VIEW SHOWS RESIDUES OF GLUE IN THE THREAD FOR THE SETTING SCREW WHICH IS THE EVIDENCE THAT THE MISSING SETTING SCREW WAS LOCKED ACCORDING TO THE SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, PATIENT WAS UNDERGOING ORIF SURGERY OF THE LEFT FEMUR. DURING THE PROCEDURE, WHILE PICKING UP THE FLEXIBLE SHAFT CONNECTOR ON THE BACK TABLE TO HAND TO THE SURGEON, A SPRING CAME OUT OF THE DEVICE AND IT WAS NOTED THAT A SCREW WAS MISSING. THEREFORE, THE DEVICE WAS NOT USED. THE SURGEON USED A HAND REAMER IN ITS PLACE. SURGERY WAS NOT PROLONGED AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT NOTED. THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145527 FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK HTO SYNTHES GMBH 2578761

    Patients

    Seq Age Sex Outcome Treatment
    1