BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3954800 · Received July 24, 2014

    Report

    Report Number
    2520274-2014-12770
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR TWO UNKNOWN 2.7MM CORTEX SCREWS. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED FOR A SHOULDER FRACTURE REPLACEMENT IN 2007. ON (B)(6) 2010, JUST UNDER HER SHOULDER THE DEVICES IMPLANTED FOR TREATMENT OF HER LEFT HUMERUS WAS NOTED TO BE LOOSE OR BACKING OUT ACCORDING TO AN X-RAY THAT WAS CONFIRMED BY THE PATIENT¿S PHYSICIAN. THE SURGEON MENTIONS THAT THE DEVICES WERE PROBABLY COMING LOOSE SINCE (B)(6) 2011. ADDITIONALLY, A PIECE OF CABLE WORKED ITS WAY OUT OF HER ARM. IT WAS REPORTED THAT THE PATIENT HAD PAIN, IRRITATION AND DISCOMFORT. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014 AT THE (B)(6) CLINIC AND WANTED TO KNOW IF ANY OF THE DOCUMENT DEVICES WERE RECALLED OR HAD ISSUES THAT THE CLINIC MAY NEED TO BE AWARE OF AT THE APPOINTMENT. THIS REPORT IS FOR TWO UNKNOWN 2.7MM CORTEX SCREWS. THIS IS REPORT 8 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433408 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1