BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER

    MDR report key: 7128215 · Received December 19, 2017

    Report

    Report Number
    2939274-2017-50361
    Event Type
    Injury
    Date Received
    December 19, 2017
    Report Date
    November 21, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982228369
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S WEIGHT IS UNKNOWN. DATE OF POSTOPERATIVE NAIL BREAKAGE IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE: HWC. INITIAL IMPLANT DATE REPORTED AS (B)(6) 2017; EXACT DATE IS UNKNOWN. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART #: 456.476S, LOT#: H089928 (STERILE) - 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT - STERILE. QUANTITY 6: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 28-APR-2016, EXPIRATION DATE: 31-MAR-2025: COMPONENT PARTS REVIEWED: 456.314.3 - LOCK DRIVER TFN, BP 55, LOT: H039397 456.315.2 - 130 DEG LOCK PRONG TFN, BP 58, 9923886 21069 - RAW MATERIAL LOT BP-80 LOT - 9857068 RECEIVED FROM ATI, CERTIFICATE OF TEST RECEIVED FROM ATI SPECIALTY MATERIALS MEET CERTIFICATE OF TEST SPECIFICATION FOR TITANIUM. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. INSPECTION SHEET FOR INSPECT / INSPECT DIMENSIONAL / FINAL INSPECTION MEET SPECIFICATION. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. A PRODUCT INVESTIGATION WAS PERFORMED. THE RETURNED 12MM/130 DEGREE TI CANNULATED TROCHANTERIC FIXATION NAIL 360MM/RIGHT (456.476S) IS A COMPONENT OF THE TITANIUM TFN SYSTEM FOR INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES TECHNIQUE GUIDE. THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DEVICE WAS FOUND TO BE BROKEN AT THE PROXIMAL LOCKING HOLE. NO ROOT CAUSE COULD BE DETERMINED WITH THE PROVIDED INFORMATION. THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED DUE TO POST-MANUFACTURING DAMAGE. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE). THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. NO DIMENSIONAL ANALYSIS IS POSSIBLE DUE TO POST-MANUFACTURING DAMAGE. CORRECTED DATA: UDI NUMBER 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 A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 DUE TO BROKEN TROCHANTERIC FIXATION NAIL (TFN). THE NAIL WAS INITIALLY IMPLANTED IN (B)(6) 2017. THE BROKEN NAIL WAS REMOVED ALONG WITH A LAG SCREW 95 MM AND LOCKING SCREW 36 MM. THE PATIENT WAS IMPLANTED WITH A NEW TFN NAIL 12/360, LAG SCREW 95 MM AND LOCKING SCREW 36 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: LAG SCREW 95 MM (PART # 04.032.095 LOT # H302966 QTY # 1), 36 MM LOCKING SCREW (PART # 458.936, LOT # H257568, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12 MM/130 DEG TI CANN TROCH FIXATION NAIL 360 MM/RIGHT-STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908084 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 456.476S H089928 10886982228369

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention