BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 95MM

    MDR report key: 5504879 · Received March 16, 2016

    Report

    Report Number
    2520274-2016-11678
    Event Type
    Injury
    Date Received
    March 16, 2016
    Report Date
    March 2, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PARTIAL LOT NUMBER PROVIDED IS: 79?0345. ORIGINAL IMPLANT DATE: (B)(6) 2015. THIS IS THE ANTICIPATED DATE OF REVISION SURGERY THAT'S SCHEDULED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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 ON AN UNKNOWN DATE IN (B)(6) 2015 A PATIENT UNDERWENT AN INITIAL OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE. AT A LATER UNKNOWN DATE THE PATIENT BEGAN TO EXPERIENCE PAIN. X-RAYS WERE TAKEN AS A RESULT AND IT WAS DISCOVERED THAT THE HELICAL BLADE HAD COLLAPSED AND BEGAN TO STICK OUT A LITTLE MORE THAT IT SHOULD. A REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2016, WHERE A SHORTER LAG SCREW WILL BE IMPLANTED. THE REPORTER CONFIRMED THAT X-RAYS WILL NOT BE MADE AVAILABLE AND THE PART WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER ADDITIONAL INFORMATION COULD BE OBTAINED. THIS COMPLAINT INVOLVES ONE DEVICE. THIS COMPLAINT INVOLVES ONE DEVICE THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160863 TFNA HELICAL BLADE 95MM ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention