BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET 1PC FLEX DRILL BIT 35

    MDR report key: 4241346 · Received November 10, 2014

    Report

    Report Number
    1818910-2014-31472
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    November 6, 2014
    Report Date
    November 6, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 DRILL CONFIRMS THE OBSERVATION. 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, (B)(4) WAS CONDUCTED ON (B)(6) 2011. 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 (B)(4) POST MARKET SURVEILLANCE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    A 35MM DRILL BIT IS BROKEN. IT NEEDS TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723932 QUICKSET 1PC FLEX DRILL BIT 35 HIPS INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. 1818910 PG210298

    Patients

    Seq Age Sex Outcome Treatment
    1