BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM-STERILE

    MDR report key: 3893407 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12144
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: HWC. IMPLANT DATE: ORIGINAL IMPLANT DATE REPORTED ONLY AS 2013. 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. 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 THERE WAS A REVISION SURGERY OF A PREVIOUSLY PERFORMED TROCHANTERIC FIXATION NAILING. THE PATIENT WAS EXPERIENCING PAIN, IT WAS CONFIRMED VIA X-RAY THAT THE HELICAL BLADE WAS PENETRATING THE FEMORAL HEAD IN THE ACETABULUM. THE SURGEON EXPLANTED ALL HARDWARE. IT WAS REPORTED THAT THE PATIENT ALSO HAD A LOCKING SCREW REMOVED IN A PRIOR REVISION SURGERY SO THE PLATE WOULD FIT BETTER ON THE FEMUR, THE COMPLAINT WAS REPORTED TO BE AGAINST A NON-SYNTHES PLATE NOT THE LOCKING SCREW. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371662 11.0MM TI HELICAL BLADE 100MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention