BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FENESTRATED SCREW 115MM - STERILE

    MDR report key: 8613550 · Received May 15, 2019

    Report

    Report Number
    2939274-2019-58050
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 17, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982098832
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 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 · 0

    CONCOMITANT DEVICES REPORTED: UNKNOWN TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL (PART #: 04.037.042S, LOT #: H761295, QUANTITY # 1), UNKNOWN HELICAL BLADE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY # 1).

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT IDENTIFIER: (B)(6). EVENT YEAR REPORTED AS 2019, EXACT DATE OF POSTOPERATIVE SCREW MIGRATION IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE: KTT. 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. PRODUCT WAS NOT RETURNED. 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, PATIENT UNDERWENT REMOVAL DUE TO CATASTROPHIC FAILURE WITH PROTRUSION OF LAG SCREW INTO PELVIS. THE TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) FENESTRATED SCREW MIGRATED THROUGH THE TITANIUM CANNULATED (TFNA) NAIL AND INTO THE PELVIS. PATIENT FELL AND RAMMED THE TITANIUM CANNULATED (TFNA) NAIL. HOSPITAL HAS MAINTAINED CONTROL OF THE IMPLANT. TFNA IMPLANTS WERE REMOVED AND WERE REPLACED BY A TOTAL HIP ARTHROPLASTY (THA). THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. INITIAL IMPLANT DATE IS (B)(6) 2019. CONCOMITANT DEVICES REPORTED: UNKNOWN TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL (PART #: 04.037.042S, LOT #: H761295, QUANTITY # 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405756 TFNA FENESTRATED SCREW 115MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.038.215S 10886982098832

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 10MM/130 DEG TI CANN TFNA 170MM - STERILE| 10MM/130 DEG TI CANN TFNA 170MM - STERILE