BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR WIRE 1.6 L150/25

    MDR report key: 2722202 · Received August 28, 2012

    Report

    Report Number
    8030965-2012-00700
    Event Type
    Injury
    Date Received
    August 28, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 2, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT FAULT COULD BE DETECTED. WE FOUND THAT THE WIRE IS BROKEN AT THE THREADED PART ABOUT 4MM BELOW THE BALL. THE THREAD FLANKS AT THE BROKEN FRAGMENT ARE BADLY DAMAGED, BUT AFTERWARDS IT CAN NOT BE DEFINED IF THIS DAMAGE WAS CAUSED DURING THE INSERTION OR DURING THE EXTRACTION OF THE FRAGMENT. THE EXACT CAUSE OF THIS OCCURRENCE CAN NOT BE DEFINED. BASED ON THE APPEARANCE OF THE FRACTURE FACE AND THE STRESS MARKS AT THE WIRE ABOVE THE BALL WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD CAUSED THIS BREAKAGE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A PROCEDURE ON THE 3RD METATARSAL. THE SURGEON USED A COMPRESSION WIRE PER THE SURGICAL TECHNICAL PERPENDICULAR TO A 3 HOLD PLATE. HE DRILLED THROUGH THE FIRST CORTEX AND AS IT PENETRATED THE SECOND CORTEX TO APPLY COMPRESSION THE WIRE BROKE AT THE JUNCTION BELOW THE OLIVE. THE SURGEON HAD TO SPLIT THE METATARSAL TO REMOVE THE WIRE AS IT WAS PROTRUDING TOO MUCH THROUGH THE SECOND CORTEX TO LEAVE IT IN. THE PROCEDURE WAS EXTENDED ABOUT 45 MINUTES AND WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPR WIRE 1.6 L150/25 COMPR WIRE 16. L150/25 HXS SYNTHES GMBH 3681401

    Patients

    Seq Age Sex Outcome Treatment
    1