BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI SOLID FEMORAL NAIL 400MM

    MDR report key: 6428483 · Received March 23, 2017

    Report

    Report Number
    3009417901-2017-10006
    Event Type
    Injury
    Date Received
    March 23, 2017
    Report Date
    March 9, 2017
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HSB
    UDI-DI
    07611819043398
    PMA / PMN Number
    K923580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: UNKNOWN DATE IN (B)(6) 2016. EXPLANTED DATE: UNKNOWN. 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

    IT IS UNKNOWN IF THE DEVICE HAS BEEN EXPLANTED OR NOT. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 464.400, LOT# 5921831. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: MAR 01, 2013. 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. 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.

    Additional Manufacturer Narrative · 1

    BASED ON THE RECEIVED PICTURE THE COMPLAINT IS CONFIRMED THAT THE DEVICE IS BROKEN. 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

    IT WAS NOTED THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN IMPLANT AND THE PATIENT ALSO EXPERIENCED A NON-UNION. IT WAS REPORTED THE DEVICE HAD BEEN IMPLANTED SOMETIME IN NOVEMBER 2016. THE EXPLANT DATE IS UNKNOWN. THE BROKEN DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. THAT PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT THE UNREAMED FEMORAL NAIL (UFN) 9MM NAIL BROKE POST-OPERATIVELY. THE PATIENT CONDITION WAS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) 9MM TI SOLID FEMORAL NAIL 400MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209670 9MM TI SOLID FEMORAL NAIL 400MM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES SALZBURG 5921831 07611819043398

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention