BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04146

    MDR report key: 3220823 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04146
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013, THAT A HARDWARE REMOVAL TOOK PLACE SEVERAL MONTHS AGO DUE TO AN INFECTION. THE HARDWARE REMOVAL PROCEDURE WAS NOT REPORTED AT THE TIME TO COMPLAINT HANDLING UNIT (CHU) BECAUSE IT WAS REPORTEDLY A PLANNED PROCEDURE. THE CONSULTANT WAS PRESENT FOR THE REMOVAL SURGERY. THE CONSULTANT WILL MEET WITH THE O.R. COORDINATOR TO PROVIDE FURTHER DETAILS OF THE REMOVAL SURGERY. IT WAS REPORTED ON (B)(6) 2013, THE SURGERY WAS A HARDWARE REMOVAL DUE TO AN INFECTED HIP. THE TFN NAIL WITH A LAG SCREW AND LOCKING BOLT WERE REMOVED DUE TO AN INFECTION. THE LAG SCREW CAN BE REMOVED WITH VICE GRIPS OR OTHER TOOLS, BUT A T-HANDLE LAG SCREW DRIVER WAS AVAILABLE AND PROVIDED BY THE SALES CONSULTANT. NO DELAY WAS REPORTED. ON 6/20/13, IT WAS REPORTED THAT THE SURGERY WAS DELAYED BY 20 MINUTES TO OBTAIN THE T-HANDLE LAG SCREW DRIVER. ON (B)(6) 2013, IT WAS REPORTED THAT THE LAG SCREW DRIVER WAS PROVIDED AS A COURTESY BECAUSE THE SURGEON DID NOT HAVE ONE. IT IS NOT CONSIDERED PART OF THE COMPLAINT. THIS REPORT IS FOR AN UNKNOWN SCREW LAG. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321049 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention