BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TFNA FEM NAIL Ø11 LE 130° L300 TIMO15

    MDR report key: 6232479 · Received January 9, 2017

    Report

    Report Number
    1719045-2017-10012
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Report Date
    December 16, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE REMAINED IMPLANTED. DEVICE HAS NOT BEEN EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.037.151S, LOT# H029035. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: FEB 11, 2016, EXPIRY DATE: JAN 31, 2026. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT SURGERY FOR FEMUR SUBTROCHANTERIC FRACTURES. BECAUSE THE PATIENT HAD AN OUTSIDE CURVATURE, THE SURGEON GENTLY INSERTED A TFNA (TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM) NAIL. HOWEVER AFTER THE SURGERY HE CONFIRMED BY AN X-RAY PHOTOGRAPH THAT THE DISTAL PORTION OF THE NAIL TOUCHED THE FRONT CORTEX. TWO (2) WEEKS AFTER THE SURGERY, HE CONFIRMED A PROJECTION OF DISTAL PORTION OF THE NAIL. NO DELAY IN SURGERY REPORTED. PATIENT AND SURGICAL OUTCOME WERE NOT REPORTED. REVISION SURGERY IS NOT PLANNED. ALSO, IT SEEMS THAT THE PATIENT WILL KEEP TERIPARATIDE TREATMENT. THE SURGEON COMMENTED THAT THE POSSIBLE CAUSE MIGHT BE THE MISMATCHING OF THE NAIL SIZE AND THE MEDULLARY CAVITY SIZE. CONCOMITANT DEVICES: TFNA SCR L80 TAN (PART# 04.038.080S, LOT# 9915498, QUANTITY 1). LOCKSCR Ø5 L40 F/NAILS TAN LIGHT GREEN (PART# 04.005.530S, LOT# L003079, QUANTITY 1). LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN (PART# 04.005.528S, LOT# L092663, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18502 TFNA FEM NAIL Ø11 LE 130° L300 TIMO15 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT H029035

    Patients

    Seq Age Sex Outcome Treatment
    1 PART# 04.005.528S, LOT# L092663, QUANTITY 1| PART# 04.005.530S, LOT# L003079, QUANTITY 1| PART# 04.038.080S, LOT# 9915498, QUANTITY 1