BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW Ø3.5 SELF-TAP L24 TAN

    MDR report key: 3142070 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02577
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE ADDITIONAL EVALUATION REPORT STATES THAT THE EXAMINATION OF THE RAW-MATERIAL INSPECTION SHEETS OF THE SUPPLIERS AND THE MANUFACTURING DOCUMENTS OF THE PRODUCER SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIALS ARE IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES WE CAN ASSUME THAT THE IMPLANT WAS SUBJECTED TO HIGH DYNAMIC LOADS. HIGH ALTERNATING 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 IMPLANT. THE IMPLANT 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. THIS COMPLAINT IS DEEMED INVALID.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT IMPLANTED WITH A PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE FOR A MID SHAFT HUMERAL FRACTURE APPROXIMATELY ONE MONTH AGO. TEN DAYS STATUS POST, PATIENT COMPLAINED OF PAIN IN HIS HUMERUS. X-RAYS SHOWED A BROKEN PLATE. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244022 LOCKING SCREW Ø3.5 SELF-TAP L24 TAN APPLIANCE, FIXATION, NAIL KTT SYNTHES GMBH 2774539

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention