BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE

    MDR report key: 4201748 · Received October 27, 2014

    Report

    Report Number
    3000270450-2014-10129
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    July 11, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDS
    PMA / PMN Number
    PK040762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE HISTORY REVIEW: NON-STERILE LOT. 7881095 - MANUFACTURING SITE: (B)(4) - MANUFACTURING DATE: APR 20, 2012 - NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT DATE IS UNKNOWN. DEVICE WAS NOT EXPLANTED. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. VENDOR OF THE CORRESPONDING NON STERILE PART: 04.004.546 LOT: 7881095 IS SYNTHES EU: MANUFACTURING LOCATION: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE NAIL AFTER SEVERAL ATTEMPTS AND THE ASSISTANCE OF SEVERAL SURGEONS, SO IT REMAINS IN SITU. PATIENT EXPERIENCED TROUBLE OF SENSITIVITY, BLOOD LOSS, EXTENSION OF SURGICAL APPROACH. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682246 11MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE NAIL, FIXATION BONE JDS SYNTHES SELZACH 7929690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention