BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED SCREW ASNIS III Ø6.5X85MM TL20MM

    MDR report key: 3181258 · Received June 21, 2013

    Report

    Report Number
    0008031020-2013-00203
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K000080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4): DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED EVENT WAS ATTRIBUTED TO A USER RELATED ISSUE. THE SALES REP. STATES THAT THERE WAS A NON-UNION AND THEREFORE WE ASSUME THAT THIS IS A CLINICALLY ISSUE. THE OP TECH ASNIS III CANNULATED SCREW SYSTEM SHOWS THAT THE SURGEON HAS TO CHOOSE THE MOST APPROPRIATE DEVICE AND TREATMENT OPTION. IN THIS CASE THE FIRST TREATMENT WAS ON (B)(6) 2013 AND AFTER ALMOST 2 MONTHS THERE WAS REVISION SURGERY BECAUSE OF NON-UNION AND THEREFORE WE ASSUME THAT THE SURGEON CHOOSE AN INAPPROPRIATE DEVICE FOR THIS TREATMENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. IF THE AFFECTED DEVICE IS AVAILABLE THE COMPLAINT WILL BE REWORKED.

    Description of Event or Problem · 1

    REMOVAL ASNIS SCREWS CONVERT TO TOTAL HIP. IT WAS REPORTED SCREWS WERE REMOVED BECAUSE THE PATIENT HAD ARTHRITIS.

    Description of Event or Problem · 1

    REMOVAL ASNIS SCREWS CONVERT TO TOTAL HIP. IT WAS REPORTED SCREWS WERE REMOVED BECAUSE THE PATIENT HAD ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282276 CANNULATED SCREW ASNIS III Ø6.5X85MM TL20MM IMPLANT HWC STRYKER OSTEOSYNTHESIS-SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention