BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET 1PC FLEX DRILL BIT 25

    MDR report key: 5140841 · Received October 9, 2015

    Report

    Report Number
    1818910-2015-32463
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 29, 2015
    Report Date
    September 29, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DRILLS CONFIRMS THE OBSERVATION; THE TOPS OF TWO OF THE DRILL BROKE OFF AND ONE WAS RECEIVED BENT. 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. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    WHILE DRILLING FOR SCREWS ON CUP, THE SURGEON HAD TWO DRILL BITS BREAK AND ONE BEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670477 QUICKSET 1PC FLEX DRILL BIT 25 HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 PG233329

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR