BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/440MM/RT-STERILE

    MDR report key: 3012081 · Received March 20, 2013

    Report

    Report Number
    1719045-2013-10397
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2012
    Report Date
    February 20, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K040336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL INFORMATION: PATIENT INITIALS (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION SHOWED THAT THE PART RECEIVED WITH NO APPARENT DAMAGE. ALL DIMENSIONS PERTINENT TO COMPLAINT WERE RE-CHECKED. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IM NAIL OF RIGHT FEMUR PROCEDURE, SURGEON HAD DIFFICULTY INSERTING THE NAIL AND DIFFICULTY REMOVING THE NAIL. SURGEON RE-REAMED THE CANAL BUT STILL HAD DIFFICULTY INSERTING AND RE-INSERTING AND REMOVING THE NAIL. SURGEON RE-REAMED AGAIN AND INSERTED A SHORTER NAIL AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS, AND WITH NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116299 12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/440MM/RT-STERILE HSB SYNTHES MONUMENT 5744189

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR