BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FENESTRATED HELICAL BLADE 100 -S

    MDR report key: 12393682 · Received August 31, 2021

    Report

    Report Number
    2939274-2021-05073
    Event Type
    Injury
    Date Received
    August 31, 2021
    Report Date
    August 2, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982099297
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: REPORTER IS A J&J SALES REPRESENTATIVE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. VISUAL INSPECTION: THE TFNA FENESTRATED HELICAL BLADE 100 -S (P/N: 04.038.400S, LOT NUMBER: H781832) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED SEVERE SCRATCHES ON THE SURFACE OF THE DEVICE LIKELY DUE TO THE IMPLANTATION AND EXPLANTATION, WHICH WAS NOT RELATED TO THE COMPLAINT CONDITION. HOWEVER, THE REPORTED CONDITION FOR BROKEN COULD NOT BE CONFIRMED FROM THE RETURNED DEVICE. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: DRAWING: 04_038_370, REV. C FEATURE: SHAFT OUTER DIAMETER SPECIFICATION: 10.35 MM +0.02/-0.03 MM MEASURED DIMENSION: 10.35 MM RESULT: CONFORMING MEASUREMENT DEVICE: CALIPER CA802 DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED TI TFNA FENESTRATED HELICAL BLADE: 04_038_370, REV. C(CURRENT AND MANUFACTURED) NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT WAS NOT CONFIRMED SINCE THE REPORTED CONDITION COULD NOT BE CONFIRMED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT - NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW - REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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) 2021, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). HELICAL BLADES, PERFORATED, STERILE (PART:04.038.400S; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100 -S. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296716 TFNA FENESTRATED HELICAL BLADE 100 -S ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.038.400S H781832 10886982099297

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 11/130 DEG TI CANN TFNA 380/LEFT - SILE| UNK - SCREWS: TRAUMA