BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7MM TI CANNULATED HUMERAL NAIL-EX/230MM

    MDR report key: 5794819 · Received July 14, 2016

    Report

    Report Number
    1719045-2016-10548
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 28, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K033071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ASIDE FROM PT. BEING MALE - PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. NOT EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. MANUFACTURING LOCATION: (B)(4) MANUFACTURING DATE: 09-DEC-2015 PART #: 04.001.226, LOT#: 9963491 (NON-STERILE) - 7MM TI CANNULATED HUMERAL NAIL - EX/230MM. 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. 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. DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, NO IMPLANT/EXPLANT DATES ARE APPLICABLE. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY FOR A FIXATION SHAFT RIGHT HUMERUS, THE NAIL BROKE. TO COMPLETE THE PROCEDURE, THE SURGEON USED ANOTHER NAIL OF THE SAME TYPE. THIS COMPLAINT INVOLVES ONE PART. IT WAS AN INITIAL SURGERY AND NO BROKEN PARTS WERE LEFT IN THE PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 20, 2016. IT WAS FURTHER REPORTED THAT THERE WAS A FIVE (5) MINUTE SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ADDITIONAL MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447854 7MM TI CANNULATED HUMERAL NAIL-EX/230MM NAIL,FIXATION,BONE JDS SYNTHES MONUMENT 9963491

    Patients

    Seq Age Sex Outcome Treatment
    1