BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø9 SM 130° L200 SST

    MDR report key: 3933894 · Received July 15, 2014

    Report

    Report Number
    9612488-2014-10281
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 17, 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

    ADDITIONAL PRODUCT CODE: HWC. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE CANNULATED PFNA IS MADE OF STAINLESS STEEL. THE EXAMINATION OF THE MANUFACTURING DOCUMENTS OF THE PRODUCER AND THE RAW-MATERIAL INSPECTION SHEET OF THE SUPPLIER SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIAL OF THE INTRAMEDULLARY NAIL IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS ISO 5832-1 AND ASTM F138 FOR SURGICAL IMPLANTS MADE OF STAINLESS STEEL. THE DIMENSIONS WERE CHECKED USING A DIGITAL SLIDING CALLIPER AND FOUND TO BE IN COMPLIANCE. MACROSCOPICALLY THE DISTAL LOCKING HOLE SHOWS MECHANICAL DAMAGES ON THE MEDIAL AND LATERAL SIDE OF THE PFNA. FURTHERMORE A CRACK IS VISIBLE ON THE MEDIAL SIDE. THESE MECHANICAL DAMAGES ARE ASSUMABLY CAUSED BY THE LOCKING BOLT. THE PROXIMAL LOCKING HOLE (LEAD-THROUGH FOR THE SPIRAL BLADE) SHOWS GLIDING-, WEAR MARKS AND FRETTING CORROSION ON THE MEDIAL SIDE. FRETTING CORROSION RESULTS FROM MICROMOVEMENTS BETWEEN THE SPIRAL BLADE AND THE PFNA. THE MICROMOVEMENTS CAUSE DAMAGE TO THE PASSIVATION LAYER OF THE METAL AND PANDER CREVICE CORROSION OR PITTING CORROSION. WHEN EXAMINING THE DISTAL FRACTURE SURFACES USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOUR WERE IDENTIFIED. THE MAIN CRACKS STARTED AT THE LATERAL SIDE AND RAN INTO THE MATERIAL. A SECOND CRACK INITIATION WAS OBSERVED ON THE MEDIAL SIDE. AFTER BREAKING, THE TWO NAIL FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING SOME DESTRUCTION OF THE FRACTURE SURFACES (ABRADED AND SHINY AREAS). AT A HIGHER MAGNIFICATION, FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES AND ALMOST OVER THE ENTIRE FRACTURE SURFACES. 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 FRACTURE SURFACES SHOWED A LIGHT SECONDARY CORROSION. THE SECONDARY CORROSION IS A RESULT OF A CREVICE SITUATION BETWEEN THE FRAGMENTS AFTER CRACK INITIATION RESPECTIVELY FROM RUBBING AGAINST EACH OTHER OF THE FRAGMENTS. THE PROCESS AFFECTS THE PASSIVATION LAYER OF THE METAL AND PANDERS CORROSION. THE AREAS WITH DIMPLES CORRESPONDS TO THE RESIDUAL FORCED FRACTURE ZONE. DOCUMENTED FATIGUE CRACKS CLOSE TO THE INITIAL FRACTURE ZONE INDICATE A MULTIPLE CRACK INITIATION. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO LOW DYNAMIC BENDING LOADS (TWO-SIDED). CONSTANTLY ALTERNATING LOAD CYCLES (DURING WALKING) LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE. THE PFNA COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE, TOO. WE FOUND NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS. 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)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD A NECK FRACTURE. AFTER IT HEALED, THE PATIENT FELL ON THE GROUND AND HAD A SUBTROCHANTERIC FRACTURE AND BREAKAGE OF THE NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411815 PFNA Ø9 SM 130° L200 SST ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH 8452466

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention