BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8445319 · Received March 22, 2019

    Report

    Report Number
    2939274-2019-57093
    Event Type
    Injury
    Date Received
    March 22, 2019
    Report Date
    February 27, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE (1) UNKNOWN - SCREWS: NAIL DISTAL LOCKING/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF THE TITANIUM CANNULATED RETROGRADE FEMORAL NAIL AND FOUR (4) UNKNOWN LOCKING SCREWS. THE PATIENT HAD A RIGHT NONUNION FEMUR DUE TO FAILURE OF HARDWARE. TWO (2) OF THE LOCKING SCREWS WERE BROKEN AND THE BROKEN PORTION OF ONE DISTAL LOCKING SCREW WAS REMOVED WHILE A PORTION OF THE PROXIMAL LOCKING SCREW REMAINED. ORIGINAL DATE OF IMPLANT WAS IN 2013. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFUL AND PATIENT STATUS WAS STABLE. CONCOMITANT DEVICES REPORTED: TITANIUM CANNULATED RETROGRADE FEMUR NAIL (PART# 04.013.540S, LOT# 6964391, QUANTITY 1 ); UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SCREWS: NAIL DISTAL LOCKING. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235704 SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention