BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM

    MDR report key: 3450518 · Received November 5, 2013

    Report

    Report Number
    2520274-2013-07122
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 8, 2013
    Manufacturer
    SYNTHES
    Product Code
    HTY
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL CODE: LRN. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.DEVICE IS AN INSTRUMENT AND NOT IMPLANTED/ EXPLANTED.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A K-WIRE BROKE DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE CLAVICLE SURGICAL PROCEDURE. IT WAS REPORTED THAT FOLLOWING THE INSERTION OF THE K-WIRE, THE SURGEON HAD DRILLED SCREWS AROUND IT. IT WAS NOTED THAT THE K-WIRE HAD BROKEN UPON REMOVAL. ALTHOUGH THE SURGEON ATTEMPTED TO RETRIEVE THE K-WIRE, ONE-THIRD OF THE K-WIRE WAS LEFT IN THE PATIENT. NO PATIENT INFORMATION WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE ONLY DEVICE REPORTED FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570021 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM HTY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1