BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER

    MDR report key: 3940965 · Received July 17, 2014

    Report

    Report Number
    1719045-2014-10318
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF DEPUY SYNTHES MONUMENT DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. 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.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED WITH DAMAGE TO THE HOLE AND THE OUTSIDE DIAMETER DAMAGED ADJACENT TO THE OBLIQUE HOLE. THE MATERIAL WAS VERIFIED AND PASSED. 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.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING EVALUATION WAS UPDATED: THE LOCKING PRONG 456.315.2 IS DAMAGED. DUE TO THIS DAMAGE, THE COMPLAINT IS CONFIRMED, BUT NOT RELATED TO THE MANUFACTURING PROCESS.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 ON (B)(6) 2014 THE PATIENT HAD A REVISION SURGERY DUE TO MIGRATION OF THE HELICAL BLADE THROUGH THE FEMORAL HEAD, LATERAL TO THE NAIL. THIS WAS DISCOVERED ON A FOLLOW UP VISIT AND X-RAY THAT WAS PERFORMED ON (B)(6) 2014. DURING THE SURGERY THE PHYSICIAN REMOVED THE HELICAL BLADE, NAIL AND ANTI-ROTATION SLEEVE ATTACHED TO THE NAIL WHICH APPEARED TO BE DAMAGED AT THE PROXIMAL END AND IMPLANTED A NEW NAIL AND LAG SCREW AND REUSED THE LOCKING SCREW FROM THE ORIGINAL SURGERY. THIS PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419748 12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7593084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention