BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 4871043 · Received June 26, 2015

    Report

    Report Number
    2520274-2015-14659
    Event Type
    Injury
    Date Received
    June 26, 2015
    Report Date
    June 16, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN NAIL/UNKNOWN LOT. ADDITIONAL PRODUCT CODE: HWC. IT IS UNKNOWN IF THE DEVICE WAS IMPLANTED/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 A TROCHANTERIC FIXATION NAIL (TFN) LAG SCREW DID NOT GO THROUGH THE NAIL DURING A PROCEDURE. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS A THIRTY (30) MINUTES TIME DELAY IN SURGERY. THIS REPORT IS FOR AN UNKNOWN NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416561 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention