BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L22 TAN

    MDR report key: 3231236 · Received July 17, 2013

    Report

    Report Number
    2520274-2013-04237
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K071184
    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. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE CHEMICAL COMPOSITION OF THE LOCKING SCREWS WAS TESTED BY (B)(4). THE SCREWS WERE FOUND TO BE MADE OF (B)(4). A SMALL PORTION OF EACH SCREW WAS SECTIONED AND PREPARED INTO A TRANSVERSAL AND LONGITUDINAL MICRO SECTION. THE TRANSVERSAL AND LONGITUDINAL MICRO SECTIONS OF ALL SCREWS SHOWED A (B)(4). THE MATERIAL WAS FREE OF ALPHA CASE. BASED ON THESE RESULTS THE CHEMICAL COMPOSITION AN D MICRO STRUCTURE OF THE SCREWS ARE IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS (B)(4) FOR IMPLANTS MADE OF (B)(4). HARDNESS MEASUREMENTS WERE TAKEN USING A VICKERS INDENTER. THE DIMENSIONS (AS FAR AS MEASURABLE) WERE CHECKED USING A DIGITAL SLIDING CALIPER AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING AND (B)(4) SPECIFICATIONS. WHEN EXAMINING THE FRACTURE SURFACES OF THE SCREW HEADS USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR WERE IDENTIFIED. THE CRACKS STARTED AT THE OUTSIDE AND RAN INTO THE MATERIAL. AFTER BREAKING, THE SCREW FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING DESTRUCTION OF THE FRACTURE SURFACES (ABRADED AREAS). AT A HIGHER MAGNIFICATION, FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES AND OVER A SIZABLE AREA. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT AND THEY ORIGINATE FROM CYCLIC LOADS (LOAD AND UNLOAD). THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE SCREWS FAILED BECAUSE OF FATIGUE AND OVERLOAD. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES, IT IS POSSIBLE THE SCREWS WERE SUBJECTED TO HIGH 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 SCREWS. THE SCREWS COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD/FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    POST-OPERATIVELY, IT WAS DISCOVERED THAT THE VARIABLE ANGLE LOCKING COMPRESSION PLATE AND A TOTAL OF FIVE LOCKING SCREWS HAD THE HEADS BROKEN OFF IN THE PATIENT. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT HAD A DISTAL RADIUS FRACTURE ON RIGHT SIDE CAUSED BY A FALL DURING A FOOTBALL MATCH. PATIENT IMPLANTED (B)(6) 2013 WITH PLATE AND SCREWS. FOLLOW UP X-RAY WAS PERFORMED (B)(6) 2013. TWENTY FIRST DAY POST OP X-RAY WAS PERFORMED AND REMOVAL OF K-WIRE UNDER LOCAL ANESTHESIA, AND STARTED GRADUAL PHYSIOTHERAPY. REPORTEDLY ON (B)(6) 2013 THE BREAKAGE OF SCREWS AND RE-DISLOCATION WAS FOUND. ON (B)(6) 2013 THE IMPLANTS WERE REMOVED AND PATIENT WAS REVISED TO A NEW VA-TCP PLATE AND LARGE SCREWS WITH TEMPORARY FIXATION WITH K-WIRE AND APPLICATION OF A LONG PLASTER SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332224 VA LOCKSCR Ø2.4 SELF-TAP L22 TAN HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention