BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL SLEEVE AXSOS 5.0MM LOCKING SET

    MDR report key: 3273346 · Received August 9, 2013

    Report

    Report Number
    0008031020-2013-00264
    Event Type
    Malfunction
    Date Received
    August 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    July 15, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE BROKEN TIP COULD BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE FULLY DETERMINED AS THE BROKEN PIECE WAS NOT RETURNED FOR EVALUATION. PROBABLE CAUSES COULD BE THE FOLLOWING: AXIAL FORCES WERE APPLIED TO THE DRILL GUIDE WHILE IT WAS NOT FULLY SEATED IN THE THREAD OF THE PLATE HOLE. THE DRILL SLEEVE WAS USED TO INSERT LOCKING INSERTS FOR WHICH IT IS NOT INTENDED DUE TO ITS CANNULATION AND SMALLER WALL THICKNESS. PLEASE PAY ATTENTION TO THE NOTE WRITTEN IN THE OPERATIVE TECHNIQUE AXSOS LOCKING PLATE SYSTEM (REF# 982301 REV 3): ¿NOTE: DO NOT PLACE LOCKING INSERTS WITH THE DRILL SLEEVE. [¿] THE DRILL SLEEVE SHOULD BE FULLY INSERTED INTO A LOCKING HOLE OR LOCKING INSERT TO ENSURE INITIAL FIXATION OF THE LOCKING INSERT INTO THE PLATE. A 4.3MM DRILL BIT (REF 702743) IS USED TO DRILL THROUGH BOTH CORTICES ( FIG. 19).¿ A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE BROKEN PIECE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    SURGEONS USED DRILL SLEEVE TO SCREW INTO THE AXSOS FEMORAL PLATE. THEN, THE TIP OF DRILL SLEEVE WAS BROKEN.

    Description of Event or Problem · 1

    SURGEONS USED DRILL SLEEVE TO SCREW INTO THE AXSOS FEMORAL PLATE. THEN, THE TIP OF DRILL SLEEVE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377803 DRILL SLEEVE AXSOS 5.0MM LOCKING SET INSTRUMENT LXH STRYKER TRAUMA SELZACH 00784Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Other