BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE

    MDR report key: 10353001 · Received July 31, 2020

    Report

    Report Number
    2939274-2020-03338
    Event Type
    Injury
    Date Received
    July 31, 2020
    Report Date
    July 9, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982097415
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: UPDATED DATA-B5, D4. 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 · 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: A2: PATIENT'S AGE AND BIRTH DATE HAVE BEEN UPDATED ACCORDINGLY. B5, B6, B7: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT; THEREFORE, THE TESTS/LAB DATA INCLUDING DATES AND MEDICAL HISTORY/PREEXISTING CONDITION HAVE BEEN UPDATED ACCORDINGLY. IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT HAD DEVELOPED VARUS COLLAPSE WITH LIKELY NONUNION AND REMOVAL OF HARDWARE AND REVISION ORIF OF NONUNION CORRECTION OF VARUS DEFORMITY. THE HELICAL BLADE IN THE TFN WAS ENCOUNTERED ON THE LATERAL CORTEX. INTRAOPERATIVE FLUOROSCOPY CONFIRMED THAT THE TFN IMPLANT HAD BROKEN AT THE BLADE/NAIL INTERFACE PROXIMALLY. OTHER UPDATES: ADDED ACCOUNT, BIRTH DATE, AGE OF EVENT, HEIGHT AND MEDICAL HISTORY, RELEVANT LAB TEST. D4, D6A, D6B: THE LOT NUMBER, IMPLANTATION AND EXPLANTATION DATES WERE REPORTED AS UNKNOWN ON THE INITIAL REPORT; AND HAVE BEEN UPDATED ACCORDINGLY. INVESTIGATION SUMMARY : THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE 12/130 DEG TI CANN TFNA 400/LEFT-STERILE WAS FOUND BROKEN IN THE INSERTION HELICAL BLADE HOLE. THE BROKEN FRAGMENTS ARE VISIBLE IN PHOTOS. NO OTHERS PROBLEMS WERE FOUND. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR 2/130 DEG TI CANN TFNA 400/LEFT-STERILE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. H10: CORRECTION NARRATIVE: D4: THE UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION.

    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

    IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION OSTEOTOMY SURGERY DURING WHICH THE FAILED AND FRACTURED HARDWARE WAS REMOVED AND REPLACED WITH NEW HARDWARE. ON (B)(6) 2016, THE PATIENT UNDERWENT AN INTRAMEDULLARY NAILING SURGICAL PROCEDURE AFTER SUSTAINING A LEFT SUBTROCHANTERIC FEMUR FRACTURE. ON OR ABOUT (B)(6) 2017, THE PATIENT INFORMED THAT THE HARDWARE HAD FAILED AND THAT ITS CANNULATED TITANIUM NAIL HAD FRACTURED. CONCOMITANT DEVICES REPORTED: TFNA 105MM HELICAL BLADE (PART# 04.038.305S, LOT# 7971267, QUANTITY (B)(4)), 5X48MM INTERLOCKING SCREW (PART# UNKNOWN, LOT# 651785, QUANTITY (B)(4)).

    Additional Manufacturer Narrative · 1

    REPORTER IS JNJ REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (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 (B)(6) 2017, THE PATIENT UNDERWENT A REVISION OSTEOTOMY SURGERY DURING WHICH THE FAILED AND FRACTURED HARDWARE WAS REMOVED AND REPLACED WITH NEW HARDWARE. ON (B)(6) 2016, THE PATIENT UNDERWENT AN INTRAMEDULLARY NAILING SURGICAL PROCEDURE AFTER SUSTAINING A LEFT SUBTROCHANTERIC FEMUR FRACTURE. ON OR ABOUT (B)(6) 2017, THE PATIENT INFORMED THAT THE HARDWARE HAD FAILED AND THAT ITS CANNULATED TITANIUM NAIL HAD FRACTURED. CONCOMITANT DEVICES REPORTED: TFNA 105MM HELICAL BLADE (PART# 04.038.305S, LOT# 651785, QUANTITY 1), 5X48MM INTERLOCKING SCREW (PART# UNKNOWN, LOT# 651785, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 12MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814054 12MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.261S 9344140 10886982097415

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention TFNA HELICAL BLADE 105MM STERILE| UNK - SCREWS: LOCKING