BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET TPRD HEX SCDR U-JOINT

    MDR report key: 3994205 · Received August 8, 2014

    Report

    Report Number
    1818910-2014-25273
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE COMPLAINT; THE DRIVER TIP WAS FRACTURED WITHIN THE HEX HEAD REGION, WITH THE TIP NOT RETURNED. THE DRIVER WAS LOADED IN TORSIONAL BENDING BEYOND THE MATERIAL LIMIT, LIKELY FROM ATTEMPTING TO USE BEYOND THE SCREWDRIVER¿S INTENDED RANGE OF MOTION, RESULTING IN A DUCTILE OVERLOAD OF THE MATERIAL AND FRACTURE OF THE DRIVER TIP. NO EVIDENCE OF MATERIAL OR METALLURGICAL DEFECTS WAS OBSERVED THAT COULD CONTRIBUTE TO THE FAILURE OF THESE COMPONENTS. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE TIP OF THE SCREWDRIVER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472713 QUICKSET TPRD HEX SCDR U-JOINT HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2011105

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR