BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM-NECKSCR Ø11 SELF-TAP L100 SST

    MDR report key: 3183335 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03218
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES, WE CAN CONCLUDE THAT THE IMPLANTS WERE SUBJECTED TO TWO-SIDED DYNAMIC BENDING AND AXIAL LOADS. GLIDING/WEAR MARKS WERE FOUND ON THE HIP PIN AND FEMORAL NECK SCREW. THEY RESULT FROM MICRO MOVEMENTS OF THE FEMORAL NAIL - PIN/SCREW AND ARE AN INDICATION FOR INSTABILITY AND HIGH DYNAMIC 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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) 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 4 OF 5 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283149 FEM-NECKSCR Ø11 SELF-TAP L100 SST HWC SYNTHES GMBH 3229188

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR