BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5507573 · Received March 17, 2016

    Report

    Report Number
    2520274-2016-11712
    Event Type
    Injury
    Date Received
    March 17, 2016
    Report Date
    February 26, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN 6.5MM MIDFOOT FUSION BOLT (LENGTH UNKNOWN). PART AND LOT NUMBERS WERE NOT AVAILABLE FOR REPORTING. BASED ON THE PRODUCT DESCRIPTION, THIS DEVICE MAY BELONG TO EITHER PART FAMILY 02.111.XXX (STAINLESS STEEL) OR 04.111.XXX (TITANIUM). THE 510(K) FOR THESE PART FAMILIES IS K081071. OTHER NUMBER¿UDI: UNKNOWN PART NUMBER, UDI: UNAVAILABLE. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION AND WAS REPORTEDLY DISCARDED BY THE HOSPITAL. WITHOUT A LOT NUMBER A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. 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 A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 DUE TO A NON-UNION OF THE ARTHRODESIS OF THE LEFT FOOT AND PAIN. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2015. THE SURGEON REMOVED THE UNKNOWN 6.5 MM MIDFOOT FUSION BOLT AND REVISED THE PATIENT TO AN UNKNOWN SYNTHES PLATE AND SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORT OF SURGICAL DELAY. THE PATIENT'S POSTOPERATIVE STATUS REPORTED AS FINE. THIS REPORT IS FOR ONE UNKNOWN 6.5 MM MIDFOOT FUSION BOLT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163723 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention