BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM

    MDR report key: 3940091 · Received July 17, 2014

    Report

    Report Number
    0009610622-2014-00340
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 31, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. THE NAIL AND LOCKING SCREW WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE SCREW WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AN INVESTIGATION OF THE SCREW WAS NOT POSSIBLE BECAUSE IT WAS NOT PROVIDED; THE ROOT CAUSE IS UNKNOWN. THE SURGERY REPORT INCLUDES THAT THE SCREW WAS ALSO BROKEN. MOST LIKELY THE SCREW BROKE DUE TO MULTIPLE LOADS AFTER THE NAIL WAS BROKEN. BECAUSE NO MANUFACTURER RELATED ISSUES WERE FOUND, THE IMPLANT BREAKAGES ARE ATTRIBUTED TO AN INTRAOPERATIVE IMPLANT DAMAGE CONTRIBUTED BY THE PATIENT. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. THE NAIL AND LOCKING SCREW WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR).THE SCREW WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AN INVESTIGATION OF THE SCREW WAS NOT POSSIBLE BECAUSE IT WAS NOT PROVIDED; THE ROOT CAUSE IS UNKNOWN. THE SURGERY REPORT INCLUDES THAT THE SCREW WAS ALSO BROKEN. MOST LIKELY THE SCREW BROKE DUE TO MULTIPLE LOADS AFTER THE NAIL WAS BROKEN. BECAUSE NO MANUFACTURER RELATED ISSUES WERE FOUND THE IMPLANT BREAKAGES ARE ATTRIBUTED TO AN INTRAOPERATIVE IMPLANT DAMAGE CONTRIBUTED BY THE PATIENT. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL BROKE, NO FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL BROKE, NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417898 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K026CD0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention