BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø3.5 SELF-TAP L26 TAN

    MDR report key: 2802524 · Received October 24, 2012

    Report

    Report Number
    2520274-2012-02508
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 25, 2012
    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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE DIMENSIONS OF THE THREE BROKEN LOCKING SCREWS WERE CHECKED (AS FAR AS MEASURABLE) AND FOUND TO BE IN ACCORDANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. THE EXAMINATION OF THE RAW MATERIAL INSPECTION SHEETS SHOWED THAT THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES OF THE LOCKING SCREWS WERE IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE LOCKING SCREW A BROKE AT THE FIRST PITCH. THE LOCKING SCREW B BROKE BELOW THE SCREW HEAD AND THE LOCKING SCREW C BROKE AT THE SIXTH PITCH. AFTER BREAKING THE FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING DESTRUCTION TO THE FRACTURE SURFACES (ABRADED/SHINY AREAS). SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE SCREW FAILURES WERE CAUSED BY FATIGUE AND OVERLOAD. THE FAILURE OF THE INVESTIGATED LOCKING SCREWS WAS DUE TO DYNAMIC BENDING WHICH LED TO OVERLOAD AND MATERIAL FATIGUE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES OF THE SCREWS A AND C, WE CAN CONCLUDE THAT THE INVESTIGATED IMPLANTS HAD TO ABSORB AND NEUTRALIZE DOUBLE SIDED BENDING MOMENTS FOR A LARGE NUMBER OF CYCLES. THE FRACTURE DIRECTION INDICATES THAT THE SCREWS A AND C FAILED BECAUSE OF DYNAMIC BENDING LOADS. THE STRONGLY ABRADED SURFACE OF THE LOCKING SCREW B IN COMBINATION WITH THE SIZEABLE AREAS OF FORCED FRACTURE ZONES SHOW THAT THE SCREW B HAD TO ABSORB AND NEUTRALIZE HIGH FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. WE ASSUME THAT SCREW B BROKE FIRST, FOLLOWED BY SCREWS A AND C. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS OF THE IMPLANTS CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT PRESENTED WITH A DISTAL TIBIAL FRACTURE WAS IMPLANTED WITH SCREWS ON (B)(6) 2012. FOUR WEEKS POST-OPERATIVE, THE SURGEON WAS ABLE TO HAVE THE PATIENT LOAD A PART OF THE BODY. THE POROSIS WAS CONFIRMED AND SIX WEEKS LATER THE PATIENT STARTED TO WALK ON CRUTCHES BECAUSE THE PATIENT HAD NO PAIN. IN THE THIRD MONTH POST-OPERATIVE, PATIENT EXPERIENCED SUDDEN PAIN. X-RAYS WERE TAKEN AND THE SURGEON CONFIRMED THREE PROXIMAL SCREWS WERE BROKEN AND PART OF THE FRACTURE WAS DISLOCATED A LITTLE. PATIENT WAS RETURNED TO THE OR ON AN UNKNOWN DATE FOR REMOVAL OF HARDWARE. UNKNOWN AS TO WHAT THE PATIENT WAS REVISED TO. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKSCR Ø3.5 SELF-TAP L26 TAN SCREW KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCREW