BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPERT TN Ø8/7 SOLID L330 TAN

    MDR report key: 3241577 · Received July 22, 2013

    Report

    Report Number
    8030965-2013-04403
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    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 IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN EVALUATION WAS CONDUCTED AND IT STATES THAT THE EXAMINATION OF THE MANUFACTURING DOCUMENTS AND THE RAW-MATERIAL INSPECTION SHEET SHOWED NO DEVIATION IN RELATION TO CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIAL IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE DIMENSIONS WERE IN COMPLIANCE TOO WITH THE TECHNICAL DRAWING OF THE CUSTOM-MADE PRODUCT. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, THE NAIL WAS SUBJECTED TO DYNAMIC BENDING AND AXIAL LOADS. CONSTANTLY ALTERNATING LOAD CYCLES LED TO THE FATIGUE OF MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD. THE IMPLANT COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD. WE FOUND NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT HAS OSTEOGENESIS IMPERFECTA. IMPLANT WAS BROKEN ON THE LEVEL OF THE DISTAL LOCKING SCREW HOLE. IN 2012 A CUSTOM MADE DEVICE ON A STANDARD TIBIA NAIL 04.024.246 WHICH WAS ADAPTED FROM A DIAMETER 8.0MM TO 7.0MM - ONLY DISTAL PART, PROXIMAL PART WAS STANDARD. IMPLANT WAS REMOVED WITHOUT COMPLICATIONS. FOR THE REOSTEOSYNTHESIS THE SURGEON USED A STANDARD 8-HOLE LOCKING COMPRESSION PLATE (LCP) MEDIAL DISTAL TIBIA PLATE 3.5 LOW BEND LEFT, 02.112.519S. THE AXIS OF THE LEG COULD BE REARRANGED, THE TREATMENT WAS STABLE. THE FIBULA HAD AN OSTEOTOMY DURING THE NAIL-SURGERY, NO FRACTURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340938 EXPERT TN Ø8/7 SOLID L330 TAN HSB SYNTHES GMBH 1001

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention