BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743

    MDR report key: 4652021 · Received April 2, 2015

    Report

    Report Number
    1719045-2015-10212
    Event Type
    Injury
    Date Received
    April 2, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 20, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK111437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EXPIRATION DATE: JULY 2016. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. C&J INDUSTRIES, INC. MANUFACTURED THE DEVICE. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF ANALYSIS AND WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. 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

    DEVICE REPORT FROM SYNTHES (B)(4): IT WAS REPORTED THAT DURING A DISTAL RADIUS OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE, THE SURGEON TRIED TO USE THE REAMER/IRRIGATOR/ASPIRATOR (RIA) TUBE ASSEMBLY WITH THE 13.0MM REAMER HEAD ON THE LEFT FEMUR. THE RIA TUBE WOULD NOT PASS DOWN THE FEMORAL SHAFT, THE SURGEON STOPPED TO EXAMINE THE REAMER TO BE SURE THE REAMER WAS SPINNING. THE SURGEON SAW THAT THE REAMER WAS SPINNING, BUT DISCOVERED THAT THE PLASTIC SHEATHING ON THE RIA TUBE ASSEMBLY WAS COVERING THE HOLES WHERE THE BONE ASPIRATE WOULD BE SUCTIONED THROUGH INTO THE RIA GRAFT FILTER. A SECOND RIA TUBE ASSEMBLY AND A REAMER HEAD WERE USED AND SURGEON WAS ABLE TO PASS OVER THE REAMING ROD AND OBTAIN LARGE AMOUNTS OF GRAFT FOR IMPLANTING INTO THE PATIENT'S RIGHT DISTAL RADIUS ORIF. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A THIRTY MINUTE DELAY. THE PATIENT'S STATUS WAS STABLE WHEN DISCHARGED FROM THE OPERATING ROOM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220130 RIA TUBE ASSEMBLY MIN 520MM LENGTH-STERILE FOR 314.743 REAMER HTO SYNTHES MONUMENT 7735315

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention