BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø2.4 SELF-TAP L22 TAN

    MDR report key: 3698417 · Received March 25, 2014

    Report

    Report Number
    2520274-2014-00959
    Event Type
    Injury
    Date Received
    March 25, 2014
    Report Date
    November 20, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K012114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE CHEMICAL COMPOSITION OF THE SCREWS WAS TESTED BY EDX. THE SCREWS WERE FOUND TO BE MADE OF (B)(4). A TRANSVERSE MICROSECTION SHOWED A HOMOGENEOUS ALPHA-BETA MICROSTRUCTURE WITH A TEXTURE OF (B)(4). BASED ON THESE RESULTS, THE CHEMICAL COMPOSITION AND MICROSTRUCTURE ARE IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS ISO 5832-11 AND ASTM F1295 FOR IMPLANTS MADE OF (B)(4). THE HARDNESS WAS MEASURED USING A VICKERS INDENTER. THE DIMENSIONS OF THE SCREWS WERE CHECKED USING A DIGITAL SLIDING CALIPER AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING AND AO/ASIF SPECIFICATIONS. WHEN EXAMINING THE SCREW HEADS OF THE LOCKING SCREWS USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR WERE IDENTIFIED. THE CRACKS STARTED AT THE OUTSIDE OF THE SCREWS AND RAN INTO THE MATERIAL. AFTER BREAKING, THE SCREW FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING LIGHT DESTRUCTION OF THE FRACTURE SURFACES (ABRADED AREAS). AT A HIGHER MAGNIFICATION, DIMPLES WERE OBSERVED AT THE CRACK PROPAGATION ZONES AND OVER THE ENTIRE FRACTURE SURFACE. THE FRACTURE SURFACE WITH DIMPLES IS TYPICAL FOR A FORCED FRACTURE BY OVERLOAD. SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE SCREW FAILURES WERE CAUSED BY OVERLOAD AS A CONSEQUENCE OF DEFORMATION ABOVE THE ELASTIC LIMIT. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE IT CAN BE CONCLUDED THAT THE IMPLANTS WERE SUBJECTED TO ONE SIDED HIGH DYNAMIC BENDING LOADS WHICH LED TO FORMATION OF CRACKS. UNDER STRONG DEFORMATION, THE GENERATION OF CRACKS AND SUBSEQUENT FAILURE OF THE IMPLANTS IS A TYPICAL BEHAVIOR OF (B)(4). POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE, TOO. NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS WAS FOUND. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT FOUR WEEKS AFTER PRIMARY OSTEOSYNTHESIS OF A DISLOCATED EXTRAARTICULAR DISTAL RADIUS FRACTURE, USING A VARIABLE ANGLE 2CP PLATE, THE PATIENT CAME INTO CONSULTATION. THE PATIENT WAS MOBILIZED FROM BED TO WHEELCHAIR USING HER RIGHT HAND WHILE FULLY LOADING HER RIGHT LEG, WITHOUT FEELING ANY SIGNIFICANT PAIN. X-RAYS INDICATED THERE WAS A DORSAL TILT OF DISTAL FRAGMENT DUE TO BREAKAGE OF ALL DISTAL SCREWS EXCEPT PROCESSUS STYLOIDEUS RADII SCREW. A SECONDARY OSTEOSYNTHESIS WAS CONDUCTED USING A VARIABLE ANGLE-VOLAR RIM PLATE, AFTER EXTRACTION OF ALL PRIMARY OSTEOSYNTHESIS MATERIAL. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 2 OF 3 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174611 LOCKSCR Ø2.4 SELF-TAP L22 TAN HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention