BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING

    MDR report key: 10567585 · Received September 22, 2020

    Report

    Report Number
    2939274-2020-04244
    Event Type
    Injury
    Date Received
    September 22, 2020
    Report Date
    August 28, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWS: LOCKING/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE IMPLANT(S) WAS NOT RETURNED AND INSTEAD THE INVESTIGATION WILL BE DONE BASED ON THE SUPPLIED IMAGE(S). THE IMAGE(S) WAS REVIEWED AND THE COMPLAINT CONDITION FOR BROKEN COULD NOT BE CONFIRMED AS THE IMAGE PROVIDED DOES NOT SHOW A BROKEN SCREW. AS THE IMPLANT(S) WAS NOT RETURNED AN AS RECEIVED CONDITION, DIMENSIONAL INSPECTION, MATERIAL OR DRAWING REVIEWS ARE NOT APPLICABLE. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. (B)(4). 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 AN UNKNOWN DATE, THAT THE PATIENT¿S SCREW BROKE POST-OP. THE ORIGINAL DATE OF IMPLANTATION WAS UNKNOWN. ON (B)(6) 2020, THE RETROGRADE /ANTEGRADE FEMORAL NAIL (RAFN) NAIL AND BROKEN DISTAL 5.0MM SCREW WERE REMOVED DUE TO NONUNION. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THERE WAS A SURGICAL DELAY OF TEN (10) TO FIFTEEN (15) MINUTES. THE REPLACEMENT OF THE NAIL TO LARGE FRAGMENT PLATES AND SCREWS WAS PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE (PART NUMBER 04.013.452, LOT H222427, QUANTITY 1), END CAPS: RAFN (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) UNKNOWN SCREWS: LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032730 UNK - SCREWS: LOCKING SCREW,FIXATION,BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention 10MM TI CANN RETRO/ANTEGRADE FEM NAIL-EX/360MM| UNK - END CAPS: RAFN| UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE