BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA 5X45 MM

    MDR report key: 10891412 · Received November 24, 2020

    Report

    Report Number
    0009610622-2020-00769
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    October 22, 2020
    Report Date
    January 26, 2021
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RECEIVED SCREW WAS FOUND TO BE BROKEN. THE ABRUPT BREAKAGE PATTERN ALONG THE EDGES, WITH A RATHER SMOOTH BREAKAGE SURFACE AND NO SIGNS OF LINES OF REST AND PLASTIC DEFORMATION, INDICATE TOWARDS A BRITTLE FRACTURE DUE TO A SUDDEN LOAD. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT FACTOR. THE FAILURE WAS CAUSED BY PATIENT FACTOR (SUCH AS BONE QUALITY, ACTIVITY, NON-UNION OR HIGH LOAD APPLICATION) RESULTED IN BRITTLE FRACTURE, WHICH CAN BE CORRELATED BY THE COMMUNICATION OF NON-UNION, EVIDENTLY CAN BE CONFIRMED BASED ON IMPLANT & EXPLANT DATES. ¿THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNIONS AND/OR NON-UNIONS. INTERNAL FIXATION DEVICES ARE LOAD SHARING DEVICES WHICH ARE INTENDED TO HOLD FRACTURED BONE SURFACES IN APPOSITION TO FACILITATE HEALING. IF HEALING IS DELAYED OR DOES NOT OCCUR, THE APPLIANCE MAY EVENTUALLY BREAK DUE TO METAL FATIGUE. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE DEVICE.¿ IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A BROKEN NAIL. PATIENT ARRIVES AT THE CLINIC WITH A BROKEN NAIL AND A BROKEN DISTAL SCREW. NO TRAUMA APPARENT, NO FURTHER HISTOLOGICAL FINDINGS, NON-UNION, NO CALCIFICATION VISIBLE IN THE FRACTURE GAP. REVISION SURGERY WITH THE "SLIDING NAIL" (COMPANY INTERCUS) SLIDE 12MM.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BROKEN NAIL. PATIENT ARRIVES AT THE CLINIC WITH A BROKEN NAIL AND A BROKEN DISTAL SCREW. NO TRAUMA APPARENT, NO FURTHER HISTOLOGICAL FINDINGS, NON-UNION, NO CALCIFICATION VISIBLE IN THE FRACTURE GAP. REVISION SURGERY WITH THE "SLIDING NAIL" (COMPANY INTERCUS) SLIDE 12MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356360 LOCKING SCREW, FULLY THREADED T2 TIBIA 5X45 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K082634

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention