BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREW ASNIS III Ø4.0X32MM TL11MM

    MDR report key: 3864977 · Received June 11, 2014

    Report

    Report Number
    0008031020-2014-00270
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K000080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 CANNULATED SCREW ASNIS III TIP BREAKAGE COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE TOO HIGH TORSIONAL FORCE WAS ATTRIBUTED TO A USER RELATED ISSUE. AS CONTACT WITH DENSE BONE CAN CAUSE DEVIATION OF THE SCREW, SUFFICIENT PRE-DRILLING AND -TAPPING SHOULD BE PERFORMED. PLEASE PAY ATTENTION TO THE OP TECH ASNIS III CANNULATED SCREW SYSTEM (REF# 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. SEE PACKAGE INSERT FOR WARNINGS, PRECAUTIONS, ADVERSE EFFECTS AND OTHER ESSENTIAL PRODUCT INFORMATION. [...] STEP 3 INSERT SCREW [...] 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

    DURING SURGERY, WHEN THE SURGEON WAS INSERTING THE SCREW TO THE PATIENT BONE AFTER THE DRILLING, THE SCREW WAS NOT INSERTED TO THE END. THE SURGEON EXTRACTED THE SCREW AND CHECKED IT, THE TIP OF THE SCREW WAS BROKEN. THE SURGEON USED ANOTHER SCREW TO COMPLETE THE SURGERY. THERE WAS 5 MINUTES DELAY IN THE SURGERY.

    Description of Event or Problem · 1

    DURING SURGERY, WHEN THE SURGEON WAS INSERTING THE SCREW TO THE PATIENT BONE AFTER THE DRILLING, THE SCREW WAS NOT INSERTED TO THE END. THE SURGEON EXTRACTED THE SCREW AND CHECKED IT, THE TIP OF THE SCREW WAS BROKEN. THE SURGEON USED ANOTHER SCREW TO COMPLETE THE SURGERY. THERE WAS 5 MINUTES DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344811 CANNULATED SCREW ASNIS III Ø4.0X32MM TL11MM SCREW, FIXATION, BONE HWC STRYKER TRAUMA SELZACH W32612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other