BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 5701084 · Received June 6, 2016

    Report

    Report Number
    1719045-2016-10461
    Event Type
    Injury
    Date Received
    June 6, 2016
    Report Date
    May 18, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS: (B)(6). DATE OF EVENT: UNKNOWN. DATE OF IMPLANT: UNKNOWN. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART 04.037.242S, LOT 9838661: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JUNE 24, 2015. EXPIRATION DATE: MAY 31, 2025. NO NON-CONFORMANCE REPORTS 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 THE SHORT TROCHANTERIC FEMORAL NAIL (TFN) POSTERIOR CUT OUT POST-OPERATIVELY. THE PATIENT WAS REVISED TO A HEMI HIP ARTHROPLASTY. NO DELAY IN SURGERY WAS REPORTED. CONCOMITANT MEDICAL DEVICES REPORTED: BLADE (PART NUMBER 04.038.275S, LOT NUMBER 7942190, QUANTITY 1) SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355723 12MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 9838661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN SCREW