BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04017

    MDR report key: 3200974 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-04017
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 1 UNKNOWN GUIDEWIRE. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THIS REPORT IS FOR AN UNKNOWN GUIDEWIRE. THE PATIENT UNDERWENT A DISTAL INTERPHALANGEAL (DIP) FUSION ON (B)(6) 2013. AS THE SURGEON WAS IMPLANTING A 2.4MM HEADLESS COMPRESSION SCREW, THE TIP OF THE SCREW BROKE OFF. THE PIECE WAS UNABLE TO BE RETRIEVED AND REMAINS IN THE PATIENT. A SECOND SCREW WAS PLACED NEXT TO THE BROKEN FRAGMENT. AS THE GUIDEWIRE WAS REMOVED, THE TIP WAS FOUND TO BE BENT. SURGERY WAS COMPLETED SUCCESSFULLY BUT WAS NOTED TO BE PROLONGED 15 MINUTES AS A RESULT OF THE BROKEN SCREW. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301675 LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1