BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR 5 SELF-TAP L80 TAN

    MDR report key: 2944881 · Received February 5, 2013

    Report

    Report Number
    8030965-2013-00325
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    November 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K962011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE EXAMINATION OF THE RAW MATERIAL INSPECTION SHEETS AND THE MANUFACTURING PAPERS SHOWS THAT THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES OF THE IMPLANTS ARE IN COMPLIANCE WITH (B)(4) FOR IMPLANTS MADE OF TITANIUM ALLOY - TAN. THE DIMENSIONS OF THE INVESTIGATED PLATE AND SCREWS, AS FAR AS MEASURABLE, WERE CHECKED. THE DIMENSIONS WERE IN COMPLIANCE WITH (B)(4) SPECIFICATIONS. WHEN EXAMINING THE DISTAL FRACTURE SURFACES, PART A AND B, OF THE PLATE AND THE HEADS OF THE SCREWS A AND B USING THE SCANNING ELECTRON MICROSCOPE - SEM, THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR COULD BE IDENTIFIED. THE CRACK OF THE PLATE STARTED AT THE UPPER SIDE OF THE PLATE AND RAN INTO THE MATERIAL. AFTER BREAKING, THE FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING STRONG DESTRUCTION OF THE FRACTURE SURFACE - ABRADED AREAS. WHEN EXAMINING THE PLATE, PATTERNS OF RIPPLES AND FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONE. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT. THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. THE FRACTURE SURFACE OF PART A SHOWS FATIGUE STRIATIONS WITH FEW DIMPLES. THE TOPOGRAPHY OF THE FRACTURE SURFACE OF PART B SHOWS A MIXED FRACTURE WITH STRUCTURAL BREAKAGE APPEARANCE AND FEW DIMPLES. STRUCTURAL BREAKAGE APPEARANCE AND DIMPLES INDICATE HIGH LOADS. WE ASSUME THAT THE PLATE BECAME HIGHLY STRESSED DURING THE FUNCTIONAL POSTOPERATIVE AND FOLLOW-UP PHASE. THE PLATE HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. BASED ON THE STRUCTURE OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE INVESTIGATED PLATE FAILED BECAUSE OF FATIGUE AND OVERLOAD. THE CRACKS OF THE SCREWS ARE UNCLEAR DUE TO SOME STRONGLY ABRADED AREAS. THEY STARTED AT THE OUTSIDE OF THE SCREWS. WHEN EXAMINING THE SCREWS A AND B, PATTERNS OF RIPPLES AND FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONE. THE TOPOGRAPHY OF THE FRACTURE SURFACES OF THE SCREWS SHOWS FATIGUE STRIATIONS WITH FEW DIMPLES. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES OF THE SCREWS, WE ASSUME THAT THE SCREWS BECAME HIGHLY STRESSED AXIALLY AND IN BENDING, LEADING TO FATIGUE AND FINALLY TO THE BREAKAGE DURING THE EXPLANTATION OF THE PREVIOUSLY DAMAGED SCREWS. WE FOUND NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH LCP DISTAL FEMUR PLATE AND SCREW CONSTRUCT ON (B)(6) 2012. THE PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE. ON (B)(6) 2012, PATIENT RETURNED TO THE HOSPITAL WITH PAIN. IT WAS NOTED THAT THE PLATE BROKE POST-OPERATIVELY, ALONG WITH TWO SCREWS. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REVISION SURGERY. SURGEON REMOVED THE HARDWARE AND PATIENT WAS REVISED WITH PLATE AND DLS. THIS IS 4 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47960 LOCKSCR 5 SELF-TAP L80 TAN SELF-TAP LOCKING SCREW KTT SYNTHES GMBH 7730016

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention