BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH

    MDR report key: 3745877 · Received April 11, 2014

    Report

    Report Number
    2520274-2014-10708
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWN
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: ONE 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH (PART 03.211.415) WAS RECEIVED FOR EVALUATION WITH COMPLAINT CATEGORY BROKEN. THE DISTAL THREADED TIP HAS FRACTURED OFF OF THE RETURNED COMPRESSION WIRE. THE FRACTURE IS MID THREAD AND IS LOCATED APPROXIMATELY 4MM DISTAL TO THE BALL/OLIVE FEATURE. TOP LEVEL PRODUCT DRAWING AND THE THREADED SHAFT COMPONENT DRAWING WERE REVIEWED DURING THIS EVALUATION. THE THREADED SHAFT COMPONENT WAS MANUFACTURED FROM MP35N WHICH IS A TYPICAL MATERIAL USED FOR MEDICAL DEVICES. MP35N ALLOY IS A NONMAGNETIC, NICKEL-COBALT-CHROMIUM-MOLYBDENUM ALLOY POSSESSING A UNIQUE COMBINATION OF ULTRAHIGH TENSILE STRENGTH (UP TO 300 KSI [2068 MPA]), GOOD DUCTILITY AND TOUGHNESS, AND EXCELLENT CORROSION RESISTANCE. IN ADDITION, THIS ALLOY DISPLAYS EXCEPTIONAL RESISTANCE TO SULFIDATION, HIGH TEMPERATURE OXIDATION, AND HYDROGEN EMBRITTLEMENT. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT. THIS COMPLAINT WAS MOST LIKELY CAUSE BY OFF-AXIS FORCE DURING COMPRESSION/DISTRACTION WHICH LED TO THE COMPRESSION WIRE BREAKING AT THE LOCATION OF SMALLEST DIAMETER/ WEAKEST GEOMETRY (DISTAL THREAD FORM). 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

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 1.6MM COMPRESSION WIRE BROKE OFF IN THE PATIENT WHILE THE SURGEON WAS PERFORMING A FUSION OF THE LEFT SECOND AND THIRD METATARSAL. WHEN THE SURGEON WAS REMOVING THE COMPRESSION WIRE, IT BROKE OFF IN THE PATIENT. THERE WAS NO ATTEMPT TO RECOVER THE FRAGMENT. THE SURGEON ELECTED TO LEAVE THE FRAGMENT WITHIN THE PATIENT WITHOUT A PLANNED FUTURE REOPERATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AND NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219835 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH INSTRUMENT COMPRESSION HWN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1