BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5001965 · Received August 13, 2015

    Report

    Report Number
    1719045-2015-10516
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT PROVIDED BY REPORTER. IMPLANT DATE MAY BE (B)(6) 2015, NOT CONFIRMED; NOT EXPLANTED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: A REVIEW OF DEPUY SYNTHES MONUMENT DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES FOR COMPLAINT NUMBER (B)(4). PART NUMBER: (B)(4), LOT NUMBER: 7971141, RAW MATERIAL NUMBER: (B)(4), MANUFACTURE DATE: 04/14/15, EXPIRATION DATE: 2025-03-31, DHR REVIEW DATE: 07/31/15, 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 CONNECTION BOLT WOULD NOT DISCONNECT FROM A NAIL AT THE END OF A TFNA PROCEDURE. THE SURGEON CRANKED ON IT AS HARD AS HE COULD AND FINALLY IT RELEASED. THIS CAUSED AN APPROXIMATE 10 MINUTE SURGICAL DELAY, AND ONE EXTRA X-RAY WAS TAKEN. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533385 11MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7971141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention