BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 CANCELLOUS BONE SCREW 35MM

    MDR report key: 1933330 · Received December 14, 2010

    Report

    Report Number
    2249697-2010-01737
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWC
    PMA / PMN Number
    K894124
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVAL: THE ROOT CAUSE OF THE REPORTED EVENT WITH ONLY THE FRACTURED HEAD OF THE BONE SCREW RETURNED FOR EVAL. HOWEVER, THE OPTICAL INSPECTION SUGGESTED THAT THE BONE SCREW FAILED IN AN OVERLOAD CONDITION DUE TO EXCESSIVE ANGULATION AND INTERFERENCE WITH THE ACETABULAR SHELL HOLE DURING INSERTION. THE RESULTS OF PREVIOUS INVESTIGATIONS FOR OTHER CANCELLOUS BONE SCREWS INDICATED THAT IMPROPER DRILLING TECHNIQUE AND/OR EXTREME ANGULATION DURING INSERTION WILL CAUSE SEIZURE OF THE BONE SCREW. THIS CAN LOCK THE BONE SCREW HALF WAY AND/OR RESULT IN INCOMPLETE SEATING OF THE SCREW. APPLYING EXCESSIVE TORQUE TO RELEASE AND/OR ATTEMPT TO SEAT THE SCREW CAN FRACTURE AND/OR DEFORM SCREW. THE ROOT CAUSE OF THIS EVENT IS LIKELY RELATED TO OPERATIVE TECHNIQUE. DEVICE HISTORY REVIEW SHOWED THAT NO REPORTED DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "SCREW BROKE DURING IMPLANTATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5 CANCELLOUS BONE SCREW 35MM IMPLANT HWC STRYKER ORTHOPAEDICS MAHWAH NA MJPEKK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention