BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 3080391 · Received April 26, 2013

    Report

    Report Number
    1719045-2013-10799
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    November 8, 2011
    Report Date
    November 8, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. THE DEVICE LISTED IN THIS REPORT IS 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 DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE PRODUCT EVALUATION AND VISUAL INSPECTION OF THE RETURNED PARTS REVEALED THAT THE LOCKING MECHANISMS ON BOTH PARTS ARE FULLY ADVANCED. THE DEVICE ASSOCIATED WITH THIS REPORT IS FULLY ADVANCED AND THE LOCKING TAB HAS BEEN BROKEN OFF. THERE ARE ALSO A LOT OF SCRAPES AND SCRATCHES INSIDE THE HOLE FOR THE HELICAL BLADE WHICH IS CONSISTENT WITH THE LOCKING MECHANISM BEING ADVANCED WHEN TRYING TO INSERT THE BLADE. THIS ISSUE HAS BEEN NOTED ON SEVERAL PREVIOUS COMPLAINTS AND AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. CONCLUSION - THIS COMPLAINT IS DEEMED VALID AND AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. PLACEHOLDER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR AN INTER-TROCHANTERIC FRACTURE, THE NAIL WOULD NOT ACCEPT THE HELICAL BLADE. IT WAS NOTED THAT THE SET SCREW HAD ALREADY BEEN ENGAGED AND BECAME DAMAGED WHILE TRYING TO INSERT THE HELICAL BLADE. THE NAIL WAS REMOVED AND UPON OPENING THE PACKAGE OF THE SECOND NAIL, IT WAS NOTED THAT THIS SET SCREW WAS ALSO ALREADY ENGAGED. A THIRD PACKAGE WAS OPENED AND THIS SET SCREW WAS NOT ENGAGED AND THE SURGEON IMPLANTED THE NAIL. APPROXIMATELY ONE HOUR WAS ADDED TO THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181345 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE HSB SYNTHES MONUMENT 6597722

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention