BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 3855370 · Received June 9, 2014

    Report

    Report Number
    2520274-2014-11703
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE/UNKNOWN LOT. ADDITIONAL PRODUCT CODE: HWC. DEVICE WAS 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

    IT WAS REPORTED THAT A SURGEON WAS FINISHING INSERTING THE HELICAL BLADE THE KNOB FELL OFF THE CONNECTING SCREW AS THE SURGEON MADE HIS FINAL HAMMER STRIKE. THE HELICAL BLADE INSERTER WAS STUCK ON THE HELICAL BLADE. AFTER UNSUCCESSFULLY TRYING TO DISCONNECT THE BLADE FROM THE INSERTER THE SURGEON BACKED OUT THE HELICAL BLADE AND SWITCHED TO A LAG SCREW. THERE WAS THIRTY MINUTE DELAY IN COMPLETING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY REPORTED. THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334266 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR