BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER

    MDR report key: 3971672 · Received July 31, 2014

    Report

    Report Number
    2520274-2014-12932
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    YEAR OF BIRTH REPORTED AS (B)(6); MONTH AND DAY UNKNOWN. THIS REPORT IS FOR AN UNKNOWN FLEXIBLE SHAFT/UNKNOWN LOT. DEVICE IS AN INSTRUMENT AND IS NOT 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN EXPERT ASIAN FEMORAL NAIL SURGERY, ON THE SHAFT REAMING PROCESS, A REAMER HEAD DETACHED FROM FLEXIBLE SHAFT. IT COULD NOT BE REMOVED AND STILL REMAINS IN THE PATIENT WITH NO REOPERATION PLANNED. THE PROCEDURE AS COMPLETED WITH A DELAY OF FIVE TO TEN MINUTES. THIS REPORT IS FOR AN UNKNOWN FLEXIBLE SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447622 REAMER HTO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1