BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE

    MDR report key: 7046744 · Received November 20, 2017

    Report

    Report Number
    1719045-2017-11203
    Event Type
    Injury
    Date Received
    November 20, 2017
    Report Date
    October 27, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE PATIENT UNDERWENT REVISION OF A TFNA NAIL DUE TO NONUNION AND BROKEN NAIL. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 26-FEB-2016 , EXPIRATION DATE: 31-JAN-2026 . PART #: 04.037.165S, LOT#: H044258 (STERILE) - 11MM/130 DEG TI CANN TFNA 440MM/LEFT- STERILE. QTY. 6. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION ,MET SPECIFICATION. COMPONENT PARTS REVIEWED: 04.037.942.2 - LOCK PRONG 130 DEGREE, TFNA BP-55 LOT ¿ 9784614, 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT ¿ 7921061 , 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT ¿ 9981032 , 21127 - RAW MATERIAL LOT BP-80 LOT ¿ 7629515. RAW MATERIAL ((B)(4)) WAS RECEIVED FROM (B)(4). CERTIFICATE OF ANALYSIS RECEIVED FOR (B)(4) FROM (B)(4) MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. NO 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. ETHICON ((B)(4)), ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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 THE PATIENT UNDERWENT REVISION OF A TFNA NAIL DUE TO NONUNION AND BROKEN NAIL. THE NAIL, HELICAL BLADE, AND DISTAL SCREW WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE BROKEN NAIL AND INTACT HELICAL BLADE AND DISTAL SCREW WERE REMOVED AND REPLACED WITH A 110 DEGREE ANGLE BLADE PLATE AND VARIOUS SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND SUCCESSFUL PATIENT OUTCOME. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITTANT MEDICAL DEVICES UNKNOWN HELICAL BLADE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) , UNKNOWN DISTAL SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823807 11MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H044258

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention