BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE

    MDR report key: 8905554 · Received August 19, 2019

    Report

    Report Number
    2939274-2019-59870
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 22, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982096715
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY LOT MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: 23-APR-2015 EXPIRATION DATE: 28-FEB-2025 PART NUMBER: 04.037.163S, 11MM/130 DEG TI CANN TFNA 420MM/LEFT- STERILE LOT NUMBER: 7961302 (STERILE) THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 04.037.942.2, LOCK PRONG, 130 DEGREE TFNA, BP55 LOT NUMBER: 9243604 PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55 LOT NUMBER: 7722159 PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58 LOT NUMBER: 7870938 PART NUMBER: 21127, TIMOAGRI16.00, BP80 LOT NUMBER: 7568481 THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT 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.

    Additional Manufacturer Narrative · 1

    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. 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, A PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DUE TO NONUNION AND DELAYED HEALING. THE NAIL WAS BROKEN AT THE LAG SCREW JUNCTION. THE LAG SCREW WAS INTACT. THE DISTAL LOCKING SCREW WAS BROKEN. ALL HARDWARE WAS REMOVED. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE BUT IT WAS REMOVED EASILY. THERE WAS A MEDICAL INTERVENTION REQUIRED TO TOTAL HIP INSERTION. THE ORIGINAL IMPLANT WAS ON (B)(6) 2019. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: TFNA FENESTRATED SCREW (PART# 04.038.195S, LOT# H723308, QUANTITY# 1) . THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701925 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.163S 7961302 10886982096715

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention TFNA FENESTRATED SCREW 95MM - STERILE| TFNA FENESTRATED SCREW 95MM - STERILE