BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 4140775 · Received October 3, 2014

    Report

    Report Number
    2520274-2014-13895
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTO
    PMA / PMN Number
    PK111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HRX. ORIGINAL SURGERY REPORTED AS 2005. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).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 DURING THE CLEANING OF DEAD BONE INFECTION OUT OF FEMORAL CANAL OF A GUNSHOT VICTIM, THE REAMER SHAFT BROKE. THE BROKEN PIECE WAS STUCK TO REAMER HEAD AND TUBING. THIS CAUSED A DELAY OF FIFTEEN MINUTES AS THE SURGEON WAS TRYING TO TAKE APART THE REAMER HEAD, TUBING AND THE BROKEN SHAFT PIECE. A LOCKING CLIP WAS NOT USED AS IT HAD FALLEN ON THE FLOOR IN THE BEGINNING OF THE SURGERY. CLEANING WAS DONE, ANTIBIOTIC CEMENT WAS PLACED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS REPORTED AS FINE. A COMPETITOR¿S POWER DRIVER WAS USED IN THIS PROCEDURE. THE ORIGINAL SURGERY WAS DONE IN 2005 AND A FEMORAL NAIL WAS PLACED (PERIFORMIS ENTRY). NO DATE ON FEMORAL NAIL REMOVAL IS KNOWN. THIS IS REPORT NUMBER 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620551 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR REAMER HTO SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1