BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED DRILL ASNIS III Ø2.7MM AO FITTING

    MDR report key: 3943161 · Received July 18, 2014

    Report

    Report Number
    0008031020-2014-00330
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE BROKEN DRILL COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE DULL/BLUNT DRILL WAS ATTRIBUTED TO A USER RELATED ISSUE. THE DEVICE INSPECTION OF THE RETURNED PIECE SHOWED THAT THE CUTTING FLUTES AND THE TIP OF THE DRILL ARE BLUNT. FURTHERMORE THERE ARE DENTS AND THE PLACE OF FRACTURE SHOWS NECKING AND REVOLVING STRESS MARKS. THESE DAMAGES MAY RESULT FROM AN INTERACTION WITH ANOTHER DEVICE OR HIGH FORCE APPLICATION. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE DRILL WAS BROKEN. ACCORDING TO SALES REP, THE WHILE DRILLING THE TIP OF DRILL BROKE. THE SURGEON REMOVED ALL FRAGMENTS.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE DRILL WAS BROKEN. ACCORDING TO SALES REP, THE WHILE DRILLING THE TIP OF DRILL BROKE. THE SURGEON REMOVED ALL FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421959 CANNULATED DRILL ASNIS III Ø2.7MM AO FITTING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other