BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPERT TIBIAL NAIL PROTECT Ø8 CANN L360

    MDR report key: 3222623 · Received July 12, 2013

    Report

    Report Number
    8030965-2013-04264
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE BLUE ANODIZED EXPERT TIBIAL NAIL IS MADE OF A TITANIUM ALLOY. THE EXAMINATION OF THE RAW MATERIAL INSPECTION SHEET OF THE SUPPLIER AND THE MANUFACTURING DOCUMENTS OF THE PRODUCER SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIAL OF THE EXPERT TIBIAL NAIL IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS ISO 5832-11 AND ASTM F1295 FOR IMPLANTS MADE OF TI6AL7NB-ALLOY. THE DIMENSIONS OF THE INVESTIGATED EXPERT TIBIAL NAIL (AS FAR AS MEASURABLE) WERE CHECKED USING A DIGITAL SLIDING CALLIPER AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. THE OUTER DIAMETER (LATERAL-MEDIAL) OF THE NAIL IS 8.3 MM, THE OUTER DIAMETER (ANTERIOR-POSTERIOR) IS 7.81 MM AND THE INNER DIAMETER OF THE CANNULATION IS 4.61 MM. THE WIDTH OF THE FOURTH DISTAL LOCKING HOLE IS 4.01 MM. THE EXPERT TIBIAL NAIL WAS IMPLANTED ON THE (B)(6) 2013 BECAUSE OF DISTAL TIBIA FRACTURE. AS FAR AS VISIBLE ON THE X-RAY IMAGES, THE NAIL WAS FIXED WITH THREE ASLS SCREWS IN THE DISTAL AREA AND TWO 4 MM SCREWS IN THE PROXIMAL PART. ACCORDING TO THE DEVICE REPORT THE BREAKAGE OF THE INTRAMEDULLARY NAIL OCCURRED WHILE THE PATIENT WALKED. THE REVISION SURGERY TO REMOVE THE BROKEN IMPLANT AND REPLACE IT BY MEANS OF A 9 MM EXPERT TIBIAL NAIL WAS PERFORMED ON THE (B)(6) 2013. THERE WAS NO REPORT WITH RESPECT TO THE AFTERCARE OF THE PATIENT. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, IT IS POSSIBLE THAT THE IMPLANT WAS SUBJECTED TO HIGH DYNAMIC BENDING LOADS (TWO-SIDED) AND PROBABLY ALSO TORSIONAL LOADS. CONSTANTLY ALTERNATING LOADS (DURING WALKING) LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE EXPERT TIBIAL NAIL. THE NAIL COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD /FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT CERTAINLY HAVE PLAYED A ROLE, TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. 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. PMA/ 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN FINLAND AS FOLLOWS: PATIENT IMPLANTED WITH AN EXPERT TIBIAL NAIL PROTECT ON (B)(6) 2013. PATIENT EXPERIENCED POST OP BREAKAGE WHILE WALKING WITH THE NAIL. PATIENT UNDERWENT REVISION SURGERY WITH RENAILING USING A 9MM DIAMETER 360MM ETN PROTECT NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322931 EXPERT TIBIAL NAIL PROTECT Ø8 CANN L360 JDS SYNTHES GMBH 7872205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention