BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE

    MDR report key: 6618510 · Received June 7, 2017

    Report

    Report Number
    1719045-2017-10539
    Event Type
    Injury
    Date Received
    June 7, 2017
    Report Date
    May 10, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS 170 CENTIMETER. (B)(4). LOT NUMBER REPORTED AS 9804242; HOWEVER IT DOES NOT CORRESPOND TO THE REPORTED CATALOG NUMBER 04.037.458S. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED TO THE RECEIVED X-RAYS WE ARE ABLE TO CONFIRM THE BREAKAGE OF THE NAIL. 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 THERE WAS A SECOND REVISION SURGERY ON (B)(6) 2017 NEEDED DUE TO A FAILED ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL. A PATIENT SUSTAINED A COMPLEX REVERSE INTERTROCHANTERIC FRACTURE OF RIGHT FEMUR ON (B)(6) 2016. THE PATIENT UNDERWENT SURGERY ON THE (B)(6) 2016; THE FRACTURE WAS REDUCED AND STABILIZED WITH ONE 1.7MM CERCLAGE CABLE AND A 235MM RIGHT TFNA WITH HELICAL BLADE (DYNAMIC LOCKING MODE). POSTOPERATIVE X-RAYS TAKEN ON (B)(6) 2016 REVEALED A BREAK IN THE LATERAL APERTURE OF THE NAIL, HOWEVER REPORTED AS NAD (NO LOSS OF REDUCTION AT THAT POINT, FINDING NOTICED RETROSPECTIVELY). THE PATIENT REPRESENTED ON (B)(6) 2017 WITH IMPLANT FAILURE AND LOSS OF REDUCTION. THE FIRST REVISION WAS PERFORMED ON (B)(6) 2017 AND BROKEN SHORT TFNA WAS REVISED TO A LONG NAIL TFNA AND AUGMENT. CONCOMITANT DEVICES REPORTED TFNA HELICAL BLADE (PART # 04.038.405S, LOT # 7883571, QUANTITY 1). THIS REPORT ADDRESSES THE SECOND REVISION SURGERY PERFORMED ON (B)(6) 2017 DUE TO FAILED TFNA NAIL. THE FIRST REVISION SURGERY PERFORMED ON (B)(6) 2017 HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 14MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401098 14MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BLADE (PART # 04.038.405S, LOT # 7883571, QTY 1)