BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04378

    MDR report key: 3222563 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04378
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 1, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 2 UNKNOWN PROXIMAL SCREWS. 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.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B)(6) 2013, THE PROXIMAL SCREW THAT WAS INSERTED INTO A PROXIMAL FEMUR PLATE BACKED OUT OF THE PATIENT. THE SECOND MOST PROXIMAL SCREW HAD ITS TIP EXTENDING INTO THE JOINT. THE SURGEON MODIFIED IT WITH A 130 DEGREE BLADE PLATE. THE ORIGINAL HARDWARE WAS REMOVED. THIS REPORT IS FOR 2 UNKNOWN PROXIMAL SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321565 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other