BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATN AR 100 MM LENGTH

    MDR report key: 2113213 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08523
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 21, 2011
    Manufacturer
    DEPUY ACE S.A. 'RL
    Product Code
    HSB
    PMA / PMN Number
    K042325
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED SCREWS CONFIRMED THE COMPLAINT. A DEPUY TRAUMA PRODUCT DIRECTOR STATES IT APPEARS THE AR SCREWS WERE FORCED IN AND THEN ADVANCED TOO FAR, POSSIBLY UNDER POWER WHICH THE SURGICAL TECHNIQUE RECOMMENDS TO INSERT MANUALLY. THE SURGICAL TECHNIQUE STATES TO ATTACH THE T-HANDLE QUICK COUPLE TO THE INSERTION WRENCH AND MANUALLY INSERT THE ASSEMBLY. WHEN THE SHOULDER OF THE INSERTION WRENCH ABUTS THE SLEEVE, THE ANTI-ROTATION SCREW HAS REACHED ITS PLANNED POSITION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    ATN ROTATION SCREW SPLAYED OUT OF HEAD WHEN INTRODUCED INTO THE PT'S BONE. PT IS ACTIVELY MOBILE. THIS ISSUE CAUSED A 40 MIN DELAY TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATN AR 100 MM LENGTH 87HSB HSB DEPUY ACE S.A. 'RL NA DLJBJ6

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR