BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 42MM

    MDR report key: 3912885 · Received July 3, 2014

    Report

    Report Number
    3003875359-2014-10192
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    KTT
    PMA / PMN Number
    PK000682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS RECEIVED CONDITION OF DEVICE ; THE PLATE IS BROKEN AS COMPLAINED. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES, THE IMPLANTS WERE SUBJECTED TO LOW DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING BENDING LOADS / LOAD CYCLES LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE IMPLANTS. THE IMPLANTS COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT DATE: IMPLANT DATES REPORTED AS (B)(6) 2014. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY IMPLANTED TO TREAT AN INTERTROCHANTERIC HIP FRACTURE ON (B)(6) 2014. THE PATIENT STATUS POST REVISIONS SURGERY IS REPORTED AS FINE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE SYNTHES IMPLANT LOCKING COMPRESSION PLATE - DYNAMIC HIP SCREW (LCP DHS) BROKE INSIDE OF THE PATIENT¿S BODY ON AN UNKNOWN DATE FIVE MONTHS POST OPERATIVELY. PATIENT HAD REOPERATION ON (B)(6) 2014 TO REPLACE THE BROKEN SCREWS. THERE WAS NO REPORT OF A SURGICAL DELAY. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391339 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 42MM APPLIANCE,FIXATION,NAIL KTT SYNTHES HAGENDORF 8615988

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention