BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM-NECKSCR Ø11 SELF-TAP L105 SST

    MDR report key: 3133070 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02450
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    February 17, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES: BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES, WE CAN CONCLUDE THAT THE IMPLANTS WERE SUBJECTED TO MODERATE DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING BENDING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE FEMORAL NECK SCREW AND TO AN INCOMPLETE FRACTURE OF THE HIP PIN. THE IMPLANTS COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE, TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. CORRECTION TO NUMBER OF REPORT FOR COMPLAINT #(B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DHR REVIEW CONFIRMS THAT THE DEVICE WAS CONFORMING TO SPECIFICATIONS; NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE SLIDING SCREW OF A PFN IMPLANTED FOR A PATHOLOGICAL TROCHANTERIC FRACTURE, BROKE 2 YEARS POST OPERATIVE. THIS REPORT IS #1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235982 FEM-NECKSCR Ø11 SELF-TAP L105 SST HSB SYNTHES GMBH 3441197

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention