BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.0MM MEDULLARY REAMER HEAD

    MDR report key: 4142233 · Received October 5, 2014

    Report

    Report Number
    2520274-2014-13899
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN REAMER/UNKNOWN LOT NUMBER. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    (B)(4). (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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

    THE REAMING ROD BALL TIP WAS NOT USED DURING THE PROCEDURE. X-RAYS TAKEN POSTOPERATIVELY SHOWED THAT THE REAMER BECAME DISCONNECTED FROM THE SHAFT OF THE REAMER AND WAS LEFT IN THE PATIENT¿S FEMUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLEXIBLE REAMER HEAD WAS USED DURING A HIP REPLACEMENT PROCEDURE. THE FLEXIBLE REAMER HEAD BECAME DISCONNECTED FROM THE FLEXIBLE SHAFT AND WAS LEFT IN THE FEMUR. IT WAS CONFIRMED THAT THE PROCEDURE WAS SUCCESSFUL. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621838 10.0MM MEDULLARY REAMER HEAD REAMER HTO

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR