BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM COMPRESSION WIRE 20MM THREAD/150MM LENGTH

    MDR report key: 3881316 · Received June 18, 2014

    Report

    Report Number
    2520274-2014-11982
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWN
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHILE REMOVING A WIRE IT BROKE ABOVE THE BALL PORTION OF THE WIRE DURING THE PROCEDURE. THE SURGEON WAS USING TWO COMPRESSION WIRES THROUGH A METATARSOPHALANGEAL FUSION PLATE TO COMPRESS PLATE TO BONE AND THEN USED COMPRESSION FORCEPS TO COMPRESS THE FIRST METATARSOPHALANGEAL JOINT AS PER SURGICAL TECHNIQUE. AFTER PUTTING IN VARIABLE ANGLE LOCKING SCREWS AS PER SURGICAL TECHNIQUE THE SURGEON ATTEMPTED TO REMOVE THE TWO COMPRESSION WIRES. ONE OF THESE WIRES BROKE ON ATTEMPTED REMOVAL ABOVE THE BALL PORTION OF THE WIRE. THE SURGEON USED A PAIR OF FORCEPS TO THEN MANUALLY ROTATE AND REMOVE THE REMAINING PART OF WIRE AND BALL PORTION OF THE BROKEN WIRE FROM THE PATIENT AND PLATE. THIS DELAYED SURGERY FOR APPROXIMATELY TWO MINUTES; THERE WAS NO REPORTED PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357298 1.6MM COMPRESSION WIRE 20MM THREAD/150MM LENGTH INSTRUMENT COMPRESSION HWN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1