BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04206

    MDR report key: 3212262 · Received July 9, 2013

    Report

    Report Number
    2520274-2013-04206
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    December 16, 2011
    Report Date
    May 16, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    THE USER FACILITY REPORTED DURING A LEFT HIP FRACTURE PROCEDURE ON (B)(6) 2011, A SYNTHES REAMER TIP BROKE AND THE HELICAL BLADE ADVANCED AND LOCKED WITH THE TIP EMBEDDED STABLY INSIDE THE LOCKED BLADE. IT WAS ALSO REPORTED HELICAL BLADE WAS USED AND BROKEN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN UNKNOWN REAMER. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312574 HTO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR