BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 4369067 · Received December 30, 2014

    Report

    Report Number
    2520274-2014-15623
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. THIS REPORT IS FOR AN UNKNOWN TROCHANTERIC FIXATION NAIL/UNKNOWN LOT. DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. WITHOUT A 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. 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 REPORTED THAT THE TROCHANTERIC FIXATION NAIL SYSTEM SCREW WAS DIFFICULT TO PASS THROUGH THE TROCHANTERIC FIXATION NAIL AND IT SEEMED LIKE THE GUIDE WIRE HAD DEFLECTED PROXIMALLY WHEN ADVANCED. THERE WAS NO REPORTED SURGICAL DELAY. PATIENT OUTCOME WAS SUCCESSFUL. UPON POST OPERATION INSPECTION IT APPEARED THE HANDLE WAS BENT.THIS REPORT IS FOR AN UNKNOWN TROCHANTERIC FIXATION NAIL. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858052 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR