BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING

    MDR report key: 3200796 · Received July 2, 2013

    Report

    Report Number
    0008031020-2013-00211
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED EVENT WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE WAS CAUSED BY THE USER. THE EXTRACTOR IS REPRESENTING A POSSIBLE OPTION OF THE REMOVAL OF A DAMAGED ASNIS III 4MM CANNULATED SCREW. AS THE GEOMETRICAL CONDITION OF A DAMAGED SCREW CANNOT BE FORSEEN IT CANNOT BE GUARANTEED THAT THE REMOVAL IS POSSIBLE WITH THE EXTRACTOR. THEREFORE OTHER OPTIONS FOR REMOVAL ARE REPRESENTED IN THE IMPLANT EXTRACTION SYSTEM, MODUL 1 ((B)(4)) AND MODUL 2 ((B)(4)). NO CORRECTION OF THE EXTRACTOR IS NECESSARY AS THE INTENDED USE OF THE DEVICE IS GIVEN. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN 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 EXTRACTION OF ASNIS 3 4.0MM SCREW, THE SCREW THREAD STOPPED AT CORTICAL BONE, AND THE SCREW COULD NOT BE EXTRACTED. THE SURGEON TRIED TO EXTRACT THE SCREW WITH PLIERS FORCIBLY, BUT THE SCREW BROKEN. HE USED THE EXTRACTOR TO EXTRACT THE BROKEN PART OF THE SCREW. THE EXTRACTOR ALSO BROKE. FINALLY, THE BROKEN PART OF THE SCREW REMAINED IN PATIENT, AND THE SURGERY WAS FINISHED.

    Description of Event or Problem · 1

    DURING EXTRACTION OF ASNIS 3 4.0MM SCREW, THE SCREW THREAD STOPPED AT CORTICAL BONE, AND THE SCREW COULD NOT BE EXTRACTED. THE SURGEON TRIED TO EXTRACT THE SCREW WITH PLIERS FORCIBLY, BUT THE SCREW BROKEN. HE USED THE EXTRACTOR TO EXTRACT THE BROKEN PART OF THE SCREW. THE EXTRACTOR ALSO BROKE. FINALLY, THE BROKEN PART OF THE SCREW REMAINED IN PATIENT, AND THE SURGERY WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303428 EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH 00811Z

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other