BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER T25 L480 F/HIP SCREWS

    MDR report key: 2822674 · Received November 7, 2012

    Report

    Report Number
    8030965-2012-01208
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL AND-OR SURGEON REPORTED: PATIENT EXPERIENCED A FRACTURE OF THE FEMORAL SHAFT AND DURING THE PROCEDURE: SURGEON WAS INSERTING THE HIP SCREW ACCORDING TO THE TECHNIQUE GUIDE WITH THE T-25 SCREWDRIVER. AS SURGEON WENT TO DETACH THE HIP SCREW FROM THE DRIVER IT WOULD NOT DETACH AND THE HIP SCREW WAS PULLED OUT WITH THE DRIVER. AFTER SOME MANIPULATION, SURGEON MANAGED TO REMOVE THE HIP SCREW FROM THE DRIVER. ANOTHER SCREW WAS SELECTED AND INSERTED, THE PROCEDURE WAS COMPLETED. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCRDRIVER T25 L480 F/HIP SCREWS SCREW DRIVER T25 HXX SYNTHES GMBH 3053039

    Patients

    Seq Age Sex Outcome Treatment
    1 HIP SCREW, T-25 SCREWDRIVER