BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NAIL LOCKING SCREW

    MDR report key: 2100432 · Received May 16, 2011

    Report

    Report Number
    9680825-2011-00005
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    February 2, 2010
    Report Date
    May 16, 2010
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K973944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL EVAL OF THE BROKEN PRODUCT USED WAS NOT PERFORMED AS THE PRODUCT HAS NOT BEEN MADE AVAILABLE FOR THE INVESTIGATION. UNFORTUNATELY, NO INFO ABOUT REAL CODE AND LOT INVOLVED IS AVAILABLE, THEREFORE, IT IS NOT POSSIBLE TO PERFORM ANY TECHNICAL INVESTIGATION. A CLINICAL INVESTIGATION OF THE CASE WAS NOT PERFORMED AS NO INFORMATION ABOUT PT CONDITIONS, MEDICAL PROCEDURE, DIAGNOSIS AND X-RAYS HAVE BEEN MADE AVAILABLE. CONSIDERING THE EVENT DESCRIPTION, A LOCKING SCREW WAS BROKEN, BUT NO INFO HAS BEEN PROVIDED ON THE ACTUAL PROCEDURE PUT IN PLACE, SUCH AS PRE AND POST OPERATIVE X-RAYS, NOR THE PRODUCT INVOLVED HAS BEEN RETURNED FOR EVAL, NOR THE PRODUCT CODE NUMBER AND LOT NUMBER HAVE BEEN DISCLOSED. ORTHOFIX TRIED TO COLLECT ALL THE INFO NECESSARY TO DETERMINE THE PT CURRENT HEALTH CONDITION IN ORDER TO VERIFY THE RESOLUTION OF THE EVENT. UNFORTUNATELY, THIS INFO WAS NOT MADE AVAILABLE. THEREFORE, IT IS NOT POSSIBLE TO DRAW ANY CONCLUSION WITH REGARDS TO THE COMPLAINED LOCKING SCREW BREAKAGE. REGARDING ORTHOFIX LOCKING SCREWS, ACCORDING TO OUR TREND RECORDS, THE FAILURE RATE IS (B)(4). IN CASE FURTHER INFO IS PROVIDED ON THE SPECIFIC APPLICATION OF THE SYSTEM (E.G. X-RAYS) OR ON THE PRODUCT INVOLVED, ORTHOFIX WILL PROMPTLY RE-OPEN THE INVESTIGATION ON THE CASE. ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    THE PT WAS SUBMITTED TO A PROCEDURE ON HIS LEFT FEMUR WITH A STAINLESS STEEL INTRAMEDULLARY NAIL ON (B)(6) 2009. ON (B)(6), 2010, HE WAS SUBMITTED TO ANOTHER SURGERY TO REMOVE THE SYSTEM AS THE SURGEON CLAIMED THAT A LOCKING SCREW WAS BROKEN. HE REALIZED THIS DURING A SESSION OF FISIOTHERAPY AND AN X-RAY. ONLY ONE LOCKING SCREW WAS BROKEN, BUT THERE IS NO INDICATION OF WHICH ONE OF THE THREE CODES USED. THE THREE CODES USER WERE: 73930, 73945, 73950. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL NAIL LOCKING SCREW FEMORAL NAIL LOCKING SCREW HSB ORTHOFIX SRL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention