BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL SYS CEM PLUG DRILLS 4.5MM

    MDR report key: 4946966 · Received July 28, 2015

    Report

    Report Number
    1818910-2015-26753
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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. (B)(4). THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: EXAMINATION OF THE RETURNED DRILL (PRODUCT CODE 2108-08-000) CONFIRMED THE TIP BROKE OFF. IT WAS DETERMINED THAT THE CEMENT PLUG DRILL WAS CYCLICALLY LOADED BEYOND THE MATERIAL LIMIT RESULTING IN A HIGH STRESS LOW CYCLE FATIGUE CRACK INITIATION, THEN QUICKLY OVER LOAD FRACTURED DUE TO A MIXED MODE OF DUCTILE AND BRITTLE OVERLOAD OF THE MATERIAL. NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS WAS OBSERVED. THE DRILL, PRODUCT CODE 2108-04-000, WAS NOT RETURNED THEREFORE EXAMINATION WAS NOT POSSIBLE. INITIAL REPORTING STATED THE SOLUTION CEMENT PLUG DRILL 4.5MM WOULD NOT BE RETURNED. A SEARCH OF THE COMPLAINT DATABASE WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. COMPLAINTS WILL BE MONITORED THROUGH POST MARKET SURVEILLANCE (B)(4). 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 REMOVING A STRYKER STEM, THE CEMENT DRILL BROKE IN THE FEMUR. LATER IN THE SURGERY, THE SECOND DRILL BROKE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECES. THE NEW STEM WAS THEN INSERTED WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489175 SOL SYS CEM PLUG DRILLS 4.5MM HIPS INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other