BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE

    MDR report key: 6440470 · Received March 28, 2017

    Report

    Report Number
    1719045-2017-10266
    Event Type
    Injury
    Date Received
    March 28, 2017
    Report Date
    March 7, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART # 04.037.157S, LOT #9959978 (STERILE) - 11MM/130 DEG TI CANN TFNA 360MM/LEFT- STERILE. QUANTITY (B)(4): MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 10-DEC-2015, EXPIRATION DATE: 30-NOV-2025. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL AND INSPECTION SHEET - TFNA ASSEMBLY INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 04.037.942.2 - LOCK PRONG 130 DEGREE, TFNA BP-55 LOT ¿ 9716606, 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT ¿ 7921051, 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT ¿ 9936509, 21127 - RAW MATERIAL LOT BP-80 LOT - 9814907. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) ON (B)(6) 2016 TO REPAIR AN UNKNOWN FEMUR FRACTURE WITHOUT INCIDENT WITH REDUCTION AND OUTCOME BOTH GOOD. ON AN UNKNOWN DATE, THE NAIL BROKE. ON (B)(6) 2017 THE BROKEN NAIL FRAGMENTS AND BLADE WERE REMOVED WITHOUT INCIDENT. A REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM WAS USED TO OBTAIN BONE GRAFT AND A 95 DEGREE, 9 HOLE ADULT BLADE PLATE WAS IMPLANTED TO STABILIZE THE FRACTURE SITE. THE BLADE LENGTH WAS 80MM. SURGERY WAS DELAYED 1 HOUR AND THE TOTAL PROCEDURE LASTED A TOTAL OF 180 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS SATISFACTORY. CONCOMITANT MEDICAL PRODUCTS: TFNA HELICAL BLADE (PART #04.038.290, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222449 11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9959978

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HELICAL BLADE (PART 04.038.290, LOT UNKNOWN, QTY 1