BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXTEND SCREW LOCK D4.5X48MM

    MDR report key: 4055922 · Received September 3, 2014

    Report

    Report Number
    1818910-2014-27170
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY IS STILL INVESTIGATING THIS COMPLAINT. UPON COMPLETION A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. THE REPORTED PRODUCT AND LOT CODE COMBINATION WAS MANUFACTURED AFTER A DESIGN CHANGE IMPLEMENTED IN 2008 (ECO269189). THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED BREAKAGE WITHOUT THE DEVICES TO EXAMINE. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    DURING INSERTION OF 48MM LOCKING SCREWS IN BOTH THE INFERIOR AND POSTERIOR HOLES OF THE METAGLENE OF THE DELTA XTEND SYSTEM, THE HEADS WERE SHEARED OFF. BOTH SCREWS BEGAN TO BECOME TIGHT AND DIFFICULT TO SEAT FULLY WITH APPROXIMATELY 3MM REMAINING. WHEN THE FIRST SCREW BECAME DIFFICULT TO SEAT FULLY, IT WAS THEN DECIDED TO REMOVE SCREW AND TRY A 42MM INSTEAD. THE HEAD WAS SHEARED OFF AT FIRST ATTEMPT OF REMOVING. THE SECOND SCREW HEAD WAS SHEARED OFF DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536415 DXTEND SCREW LOCK D4.5X48MM EXTREMITY IMPLANT LXH 3003895575 DEPUY FRANCE S.A.S 5075210

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR