BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFN Ø10 CANN LE 130° L340 SST

    MDR report key: 3183311 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03926
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 23, 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR EVALUATION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE EXAMINATION OF THE RAW MATERIAL FOR THE PFN, HIP PIN AND THE LOCKING BOLT WERE REVIEWED AND MET SPECIFICATIONS. ALL PARTS WERE MEASURED AND MET SPECIFICATIONS AND ARE IN COMPLIANCE WITH THE AO/ASIF SPECIFICATIONS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES, WE CAN CONCLUDE THAT THE IMPLANTS, PFN, HIP PIN AND LOCKING BOLT, WERE SUBJECTED TO TWO-SIDED DYNAMIC BENDING AND AXIAL LOADS. CONSTANTLY ALTERNATING BENDING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE PROXIMAL FEMORAL NAIL, THE HIP PIN AND THE LOCKING BOLT. THE IMPLANTS COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE FATIGUE FAILURES. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE, TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN PERU AS FOLLOWS: PATIENT WAS IMPLANTED WITH HARDWARE ON (B)(6) 2011. REPORTEDLY, IN THE PATIENTS LAST CONSULT IN (B)(6) 2013, THE RADIOGRAPHY HAD REVEALED A BROKEN LOCKING BOLT. IT WAS REPORTED THE DOCTOR HAD INFORMED THE PATIENT TO CONTINUE WALKING NORMALLY. IN THE LAST FOUR WEEKS, THE PATIENT FELT PAIN. ANOTHER RADIOGRAPHIC CONTROL WAS TAKEN (DATE UNKNOWN) REVEALED A BROKEN PFN NAIL. THE PATIENT REPORTED THAT HE DID NOT NOTICE THE EXACT MOMENT WHEN THE IMPLANT WAS BROKEN. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 5 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283023 PFN Ø10 CANN LE 130° L340 SST HSB SYNTHES GMBH 2710040

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention