BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA SCREW 85MM - STERILE

    MDR report key: 6234334 · Received January 9, 2017

    Report

    Report Number
    3003506883-2017-10003
    Event Type
    Injury
    Date Received
    January 9, 2017
    Report Date
    December 14, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA SCREW 85MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    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 TFN-ADVANCED¿ PROXIMAL FEMORAL NAILING SYSTEM (TFNA) THAT WAS IMPLANTED APPROXIMATELY THREE (3) MONTHS PRIOR WAS EXPLANTED ON (B)(6) 2016 DUE TO CUT-OUT OF THE LAG SCREW THROUGH THE SUPERIOR ASPECT OF THE FEMORAL HEAD AND DELAYED HEALING. THE NAIL, LAG SCREW, AND DISTAL INTERLOCK SCREW WERE REMOVED WITHOUT ANY DIFFICULTY OR SURGICAL DELAY. THE PATIENT WAS REVISED TO A MODULAR NECK STEM. CONCOMITANT DEVICES REPORTED: 12MM/130 DEG TI CANN TFNA 170MM - STERILE (PART NUMBER 04.037.242S, LOT NUMBER H162702, QUANTITY 1); 5.0MM INTERLOCKING 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
    16366 TFNA SCREW 85MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA H115948

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 4.037.242S, 12MM/130 DEG TI CANN TFNA 170MM, QTY 1| UNKNOWN, 5.0MM INTERLOCKING SCREW, QTY 1.