BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET 1PC FLEX DRILL BIT 35

    MDR report key: 4101920 · Received September 19, 2014

    Report

    Report Number
    1818910-2014-28489
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. 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..

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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

    IT WAS REPORTED BY THE REP THAT THE SURGEON WAS ATTEMPTING TO DRILL HOLES TO ADD SCREWS TO SECTOR II CUP USING THE ABOVE MENTIONED DRILL BITS USING THE DRILL GUIDE. THE 2 DRILL BITS BROKE. BROKEN BITS WERE RETRIEVED USING A LOCKER. DRILL BITS WERE SUBSEQUENTLY THROWN INTO A SHARPS CONTAINER BY HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582398 QUICKSET 1PC FLEX DRILL BIT 35 HIP INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1