BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI SOLID FEMORAL NAIL 400MM

    MDR report key: 6439118 · Received March 28, 2017

    Report

    Report Number
    3009417901-2017-10008
    Event Type
    Injury
    Date Received
    March 28, 2017
    Report Date
    March 9, 2017
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HSB
    PMA / PMN Number
    K923580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. IMPLANT DATE IS (B)(6) 2016, EXACT DATE IS UNKNOWN. EXPLANT DATE: UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE WAS REPORTED BENT AND THE PATIENT HAD A NONUNION WHICH LEAD TO A REVISION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART # 464.400, LOT # 5921831: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 01.MAR.2013. NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A 100% INSPECTION OF THE PENDING IS PERFORMED AND DOCUMENTED IN INSPECTION SHEET AT OPERATION "(B)(6)." 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 FOLLOWS: IT WAS REPORTED THAT THE FEMORAL NAIL WAS BENT POSTOPERATIVELY. ORIGINAL IMPLANT DATE IS IN (B)(6) 2016, EXACT DATE IS UNKNOWN. THERE WAS A NON-UNION DUE TO THE BENT NAIL. THE EXPLANT SURGERY WAS PERFORMED ON AN UNKNOWN DATE. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO OTHER MEDICAL INTERVENTION NEEDED. THERE WAS NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221652 9MM TI SOLID FEMORAL NAIL 400MM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES SALZBURG 5921831

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention