BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II Ø10 LONG LE 125° L320 TAN

    MDR report key: 4140159 · Received October 3, 2014

    Report

    Report Number
    9612488-2014-10423
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 6, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS PERFORMED. THE PROXIMAL FEMORAL NAIL ¿ ANTIROTATION (PFNA) WAS IMPLANTED IN (B)(6) 2014. THE REVISION SURGERY TO REMOVE THE BROKEN IMPLANT WAS PERFORMED ON (B)(6) 2014. THERE WAS NO REPORT WITH RESPECT TO THE AFTERCARE OF THE PATIENT. THE BREAKAGE OF THE PFNA REPORTEDLY OCCURRED ON APPROXIMATELY (B)(6) 2014 AT THE PROXIMAL LOCKING HOLE (LEAD-THROUGH FOR THE SPIRAL BLADE). THE DIMENSIONS OF THE CANNULATED PFNA (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. INSIDE THE PROXIMAL LOCKING HOLE AND ON THE SPIRAL BLADE, GLIDING WEAR MARKS WERE OBSERVED. THE ANODIZED SURFACE OF THE PFNA SHOWED DISCOLORATION OF THE ANODIC LAYER IN THE PROXIMAL AREA, WHICH APPEAR TO BE CAUSED BY MICROMOVEMENTS OF THE BONE AND PFNA RUBBING AGAINST EACH OTHER. WHEN EXAMINING THE FRACTURE SURFACES OF THE PFNA USING SCANNING ELECTRON MICROSCOPE, THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR WERE IDENTIFIED. THE CRACK STARTED AT THE LATERAL SIDE OF THE PFNA AND RAN INTO THE MATERIAL. AFTER BREAKING, THE TWO NAIL FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING SOME DESTRUCTION OF THE FRACTURE SURFACES. AT A HIGHER MAGNIFICATION, FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES AND OVER A SIZEABLE AREA OF THE FRACTURE SURFACES. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT AND THEY ORIGINATE FROM CYCLIC LOADS. THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO HIGH ALTERNATING BENDING LOADS. CONSTANT 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 PFNA. THE NAIL COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT AND A POSSIBLE INSTABILITY OF THE BONE FRACTURE (NON-UNION) MAY HAVE PLAYED A CERTAIN ROLE, TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT DEVELOPED SYNOSTOSIS AND CALLUS. ADDITIONAL PRODUCT CODE: HWC. IMPLANT DATE REPORTED AS: (B)(6) 2014. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE ARE NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT THE INITIAL SURGERY OF 31-A32 CASE WAS OPERATED IN (B)(6) 2014. WHILE RECEIVING HER REHABILITATION SUPPORT, THE PATIENT COMPLAINED SUDDEN PAIN ON HER HIP JOINT AND VISITED THE FACILITY ON (B)(6) 2014. THEN IT WAS FOUND THAT THE LONG NAIL IN QUESTION WAS BROKEN. ON (B)(6), THE SURGEON RE-OPERATED PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) FOR THIS EVENT. THE SURGEON COMMENTED IT WAS SEEN A BIT OF VARUS DEFORMITY AT AROUND (B)(6). THE EXACT DATE WAS UNKNOWN, BUT APPROXIMATELY TWO WEEKS BEFORE THE BREAKAGE AND IT WAS REPORTED THAT SYNOSTOSIS AND A CALLUS OF THE PATIENT PROGRESSED SLOWLY AND WAS DISCOVERED DURING A FOLLOW-UP. THIS IS REPORT NUMBER 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620933 PFNA-II Ø10 LONG LE 125° L320 TAN NAIL, FIXATION, BONE JDS SYNTHES BETTLACH 8502864

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention