BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREW ASNIS III Ø4.0X44MM TL15MM

    MDR report key: 3865153 · Received June 11, 2014

    Report

    Report Number
    0008031020-2014-00272
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 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

    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 FORCES 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.

    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 ASNIS3 SURGERY, AFTER THE SCREW INSERTION, THE SURGEON DETERMINED THE SCREW EXTRACTION BECAUSE THAT THE SCREW WAS TOO LONG FOR THE DRILL HOLE. WHEN THE SCREW WAS EXTRACTED THE TIP WAS FOUND TO BE BROKEN. THE TIP COULD NOT BE EXTRACTED. A NEW SHORTER SCREW WAS USED AND THE SURGERY WAS FINISHED AS IT IS.

    Description of Event or Problem · 1

    DURING ASNIS3 SURGERY, AFTER THE SCREW INSERTION, THE SURGEON DETERMINED THE SCREW EXTRACTION BECAUSE THAT THE SCREW WAS TOO LONG FOR THE DRILL HOLE. WHEN THE SCREW WAS EXTRACTED THE TIP WAS FOUND TO BE BROKEN. THE TIP COULD NOT BE EXTRACTED. A NEW SHORTER SCREW WAS USED AND THE SURGERY WAS FINISHED AS IT IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344752 CANNULATED SCREW ASNIS III Ø4.0X44MM TL15MM SCREW, FIXATION, BONE HWC STRYKER TRAUMA SELZACH R06360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other