BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 50MM

    MDR report key: 19760449 · Received July 17, 2024

    Report

    Report Number
    3012966183-2024-00008
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 16, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00819917025224
    PMA / PMN Number
    K133842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED UNDER MAGNIFICATION, REVEALING WEAR AND DAMAGE WITHIN THE HEXALOBE, INDICATING EXCESSIVE FORCE DURING SCREW INSERTION. THE SCREW'S SHAFT WAS ALSO FOUND TO BE DEFORMED INTO A CURVE, SUGGESTING THAT THE SCREW EXPERIENCED BOTH TRANSVERSE SHEAR AND TORSIONAL SHEAR STRESS. FURTHER EVIDENCE OF COMBINED LOADING IS OBSERVED IN THE FRACTURE PATTERN AT THE FAILURE SITE, WHERE PART OF THE FRACTURE PEELS INWARD TOWARDS THE CENTRAL AXIS OF THE SCREW AT THE POINT OF INTERSECTION WITH THE OUTER EDGE OF THE SCREW'S DEFORMED CURVATURE. MEASUREMENTS WERE TAKEN OF THE DEVICE'S SHAFT DIAMETER AND CANNULATION DIAMETER, AND BOTH FEATURES WERE FOUND TO BE WITHIN DEVICE SPECIFICATIONS (SHAFT DIAMETER: 2.999MM, CANNULATION DIAMETER: 1.764MM), SO ADEQUATE WALL THICKNESS WAS PRESENT. ALL DEVICES WITHIN LOT 200831 WERE FOUND TO MEET SPECIFICATION THROUGH INSPECTIONS PERFORMED BOTH INTERNALLY AT TYBER MEDICAL AND EXTERNALLY BY THE COMPONENT SUPPLIER. A DEVICE EVALUATION FOUND THAT ADEQUATE WALL THICKNESS WAS PRESENT ON THE IMPLANT TO RETAIN STRUCTURAL INTEGRITY. EVIDENCE OF COMBINED TRANSVERSE AND TORSIONAL LOADING SUGGESTS THAT THE FAILURE IS USER RELATED, ALTHOUGH A CONCLUSIVE ASSESSMENT OF USER ERROR CANNOT BE MADE WITHOUT IMAGING FROM THE PROCEDURE. THE ROOT CAUSE OF THE FAILURE, HOWEVER, CANNOT BE TRACED TO THE DEVICE.

    Description of Event or Problem · 0

    REPORTED FROM CUSTOMER: PROCEDURE: FOOT SURGERY. IT WAS REPORTED THAT ON (B)(6) 2024 5.5MM CCHS 50MM SCREW BROKE DURING INSERTION. SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINS OF SURGICAL DELAY. PART OF THE BROKEN SCREW WAS REMOVED AND THE SURGEON BONE GRAFTED THE FRACTURE SITE. FRAGMENTS WERE GENERATED. PATIENT OUTCOME WAS UNKNOWN. THE SCREW WAS BROKEN IN TO 3 PIECES AND 2 OF THE PIECES WERE RETAINED. 5.5MM CCHS 50MM SCREW BROKE DURING INSERTION: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 30 MIN. ACTION TAKEN WHEN EVENT OCCURRED? PART OF THE BROKEN SCREW WAS REMOVED AND THE SURGEON BONE GRAFTED THE FRACTURE SITE. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES: PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NOT AT THIS TIME. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. TYBER MEDICAL RETRIEVED ADDITIONAL INFORMATION FROM CUSTOMER: THE CCHS (CANNULATED COMPRESSION HEADLESS SCREW) BROKE INTO 3 PIECES. ONLY 1 PART WAS RETRIEVABLE. THE OTHER 2 PARTS WERE LEFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719371 5.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 50MM TYBER MEDICAL CCHS TRAUMA SCREW HWC TYBER MEDICAL 04.334.650 200831 00819917025224

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Other