BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW VARIAX FULL THREAD 2.7MM / L16MM

    MDR report key: 3141292 · Received June 3, 2013

    Report

    Report Number
    0008031020-2013-00169
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K101056
    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: BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED EVENT WAS ATTRIBUTED TO A USER RELATED ISSUE. THE THREAD ON THE SCREW HEAD WAS DAMAGED BY ANOTHER ITEM. IF THE THREAD ON THE HEAD IS DAMAGED THE LOCKING MECHANISM DOESN'T WORK PROPERLY. PLEASE FOLLOW EXACTLY THE OP-TECH TO LOCK THE SCREW IN THE PLATE AND DO NOT RECOMMEND ITEMS WITH THE SCREW. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING VARIAX ELBOW SURGERY, ALTHOUGH THE SURGEON INSERTED THE LOCKING SCREW IN PLATE SCREW HOLE, THE LOCKING SCREW WAS NOT ABLE TO BE LOCKED TO PLAT E(THE SURGEON TRIED ABOUT 5 TIMES). THEREFORE, THE SURGEON CHANGED THE LOCKING SCREW TO ANOTHER OF THE SAME SIZE AND COMPLETED THE OPERATION.

    Description of Event or Problem · 1

    DURING VARIAX ELBOW SURGERY, ALTHOUGH THE SURGEON INSERTED THE LOCKING SCREW IN PLATE SCREW HOLE, THE LOCKING SCREW WAS NOT ABLE TO BE LOCKED TO PLATE(THE SURGEON TRIED ABOUT 5 TIMES). THEREFORE THE SURGEON CHANGED THE LOCKING SCREW TO ANOTHER OF THE SAME SIZE AND COMPLETED THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244397 LOCKING SCREW VARIAX FULL THREAD 2.7MM / L16MM IMPLANT HRS STRYKER OSTEOSYNTHESIS-SELZACH Z27803

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other