BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø10 LONG R 130° L380 TAN

    MDR report key: 4143110 · Received October 6, 2014

    Report

    Report Number
    9612488-2014-10427
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: IMPLANT DATE: (B)(6) 2014, EXACT DATE UNKNOWN. A MANUFACTURING EVALUATION WAS PERFORMED. THE NAIL WAS RECEIVED IN A BROKEN STATE. THE PROXIMAL FEMORAL NAIL ¿ ANTIROTATION (PFNA) WAS IMPLANTED IN (B)(6) 2014. ACCORDING TO THE DEVICE REPORT THE BREAKAGE OF THE PFNA OCCURRED ON (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 OCCURRED AT THE PROXIMAL LOCKING HOLE (LEAD-THROUGH FOR THE SPIRAL BLADE) CLOSE TO THE AREA OF THE BONE FRACTURE. THE DIMENSIONS OF THE PFNA WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING AND AO/ASIF SPECIFICATIONS. INSIDE THE PROXIMAL LOCKING HOLE GLIDING WEAR MARKS WERE OBSERVED. THE ANODIZED SURFACE OF THE PFNA SHOWED SEVERAL DISCOLORATIONS OF THE ANODIC LAYER IN THE PROXIMAL AREA. IT IS LIKELY THAT THE DISCOLORATIONS OF THE ANODIC LAYER WERE CAUSED BY MICROMOVEMENTS, RESPECTIVELY FROM RUBBING OF THE BONE AND THE PFNA AGAINST EACH OTHER. MACROSCOPIC VISIBLE LINES OF REST WERE SHOWN ON THE POSTERIOR FRACTURE SURFACES RUNNING IN A SERIES OF CONCENTRIC RINGS FROM THE LATERAL TO THE MEDIAL SIDE. LINES OF REST ARE A TYPICAL SIGN FOR A FATIGUE FAILURE. THE PFNA SHOWED PARTLY STRONG MECHANICAL DAMAGES WHICH ARE PROBABLY CAUSED DURING THE IMPLANT RETRIEVAL. WHEN EXAMINING THE PROXIMAL FRACTURE SURFACES OF THE PFNA USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOUR WERE IDENTIFIED. THE PRIMARY 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 (ABRADED AND SHINY AREAS). THE ANTERIOR FRACTURE SURFACE OF THE PFNA SHOWED PARTLY SOME STRONG MECHANICAL DAMAGES. A SECONDARY CRACK INITIATION ZONE WAS OBSERVED ON THE MEDIAL SIDE. AT A HIGHER MAGNIFICATION, FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES AND ALMOST OVER THE ENTIRE FRACTURE SURFACE. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT AND THEY ORIGINATE FROM CYCLIC LOADS (LOAD AND UNLOAD DURING WALKING). THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. THE AREA WITH DIMPLES CORRESPONDS TO THE RESIDUAL FORCED FRACTURE ZONE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO LOW ALTERNATING BENDING LOADS (TWO-SIDED). 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 MAY HAVE ALSO PLAYED A CERTAIN ROLE. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE EVENT TOOK PLACE APPROXIMATELY FIVE MONTHS POST OPERATIVELY ON AND (B)(6) 2014. NOW THE NAIL IS BEND OR BROKEN IN THE PROXIMAL PART, FROM THE BLADE HOLE AND UP. THE SURGEON IS NOT SURE IF IT IS BROKEN OR BENT BUT WANTED TO REPLACE IT WITH A NEW PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) LONG. THERE WERE NO REPORTS OF A SURGICAL DELAY. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623679 PFNA Ø10 LONG R 130° L380 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES BETTLACH 8642338

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention