BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREW ASNIS III Ø4.0X70MM TL23.5MM

    MDR report key: 3982563 · Received August 6, 2014

    Report

    Report Number
    0008031020-2014-00354
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K000080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 SCREW COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE MOST PROBABLY WAS CAUSED BY HARD/DENSE BONE. PLEASE PAY ATTENTION TO THE OPERATIVE TECHNIQUE ASNIS III CANNULATED SCREW SYSTEM (LITERATURE NUMBER: US VERSION: LA3SB REV 6 OUS VERSION: 982187 REV 5): ¿NOTE: CONTACT OF AN ASNIS III SCREW WITH DENSE BONE IN A TANGENTIAL DIRECTION MAY CAUSE A DEVIATION OF THE SCREW AND/OR A BENDING OF THE K-WIRE, WHICH MAY RESULT IN DAMAGE TO THE IMPLANT. NOTE: IN DENSE BONE, PUNCTURING THE CORTEX WITH THE Ø1.4 X 150MM DRILL BIT TO INITIATE THE WIRE MAY REDUCE HEAT BUILD-UP AND/OR DEFLECTION OF THE WIRE. ALTERNATIVE: SUBSTITUTE THE Ø1.4 X 150MM GUIDE WIRE WITH A Ø1.4 X 150MM DRILL BIT. THROUGHOUT THE PROCEDURE IT IS POSSIBLE TO INTERCHANGE THE GUIDE WIRE AND DRILL BIT. NOTE: GUIDE WIRES ARE SINGLE USE DISPOSABLES. DO NOT REUSE GUIDE WIRES. OPTION: A PARALLEL DRILL GUIDE IS AVAILABLE FOR PARALLEL PLACEMENT OF GUIDE WIRE. [¿] THE SELF-CUTTING AND SELF-TAPPING TIP OF THE ASNIS 4.0MM SCREW IS INTENDED FOR CANCELLOUS BONE. IN DENSE CORTICAL BONE PRE-DRILLING WITH THE CANNULATED DRILL O2.7MM (702449) AND USE OF THE CANNULATED TAP O4.0MM (702454) IS RECOMMENDED, ESPECIALLY WHEN PLACING OBLIQUE SCREWS.¿ [ORIGINAL STATEMENT] 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.

    Description of Event or Problem · 1

    THE PHARMACIST REPORTED THE FOLLOWING EVENT: "THE SCREW FRACTURED DURING INTRODUCTION. ANOTHER SCREW WAS USED. NO IMPACT FOR THE PATIENT."

    Description of Event or Problem · 1

    THE PHARMACIST REPORTED THE FOLLOWING EVENT: "THE SCREW FRACTURED DURING INTRODUCTION. ANOTHER SCREW WAS USED. NO IMPACT FOR THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461423 CANNULATED SCREW ASNIS III Ø4.0X70MM TL23.5MM SCREW, FIXATION, BONE HWC STRYKER TRAUMA SELZACH Z11246

    Patients

    Seq Age Sex Outcome Treatment
    1 Other