BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET 1PC FLEX DRILL BIT 45

    MDR report key: 3946003 · Received July 21, 2014

    Report

    Report Number
    1818910-2014-23815
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    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 DRILLS CONFIRMS THE REPORT. A COMPLAINT DATABASE SEARCH HAS IDENTIFIED A TREND FOR THIS FAILURE WITHIN THE 2274 QUICKSET DRILL FAMILY. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT USE ERROR IS THE LIKELY ROOT CAUSE. AS A RESULT OF TRENDING HEALTH HAZARD EVALUATION, DVA-106292-HHE WAS CONDUCTED. THE INVESTIGATION DID NOT ESTABLISH THE NEED FOR CORRECTIVE ACTION. NO EVIDENCE WAS FOUND OF PRODUCT OR DESIGN ERROR AS A CONTRIBUTING FACTOR. SUBSEQUENT COMPLAINTS WILL BE MONITORED UNDER SEP 419 POST MARKET SURVEILLANCE. 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.

    Description of Event or Problem · 1

    INSTRUMENTS BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425270 QUICKSET 1PC FLEX DRILL BIT 45 HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. PG219821

    Patients

    Seq Age Sex Outcome Treatment
    1