BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAMER

    MDR report key: 6134530 · Received November 30, 2016

    Report

    Report Number
    2520274-2016-15524
    Event Type
    Injury
    Date Received
    November 30, 2016
    Report Date
    November 10, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DAVIS, R.L., TAYLOR, B.C., JOHNSON, N., FERREL, J.R. AND CASTANEDA, J. (2015). RETROGRADE VERSUS ANTEGRADE FEMORAL BONE GRAFT HARVESTING USING THE REAMER¿IRRIGATOR¿ASPIRATOR. J ORTHOP TRAUMA. 29:370¿372. THIS REPORT IS FOR AN UNKNOWN REAMER¿IRRIGATOR¿ASPIRATOR (RIA) SYSTEM/UNKNOWN LOT/QUANTITY UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE: HRX. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    ADDITIONAL NARRATIVE: 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE DAVIS, R.L., TAYLOR, B.C., JOHNSON, N., FERREL, J.R. AND CASTANEDA, J. (2015). RETROGRADE VERSUS ANTEGRADE FEMORAL BONE GRAFT HARVESTING USING THE REAMER¿IRRIGATOR¿ASPIRATOR. J ORTHOP TRAUMA. 29:370¿372. THE OBJECTIVE OF THE STUDY WAS TO COMPARE RETROGRADE VERSUS ANTEGRADE FEMORAL BONE GRAFT HARVESTING USING THE REAMER¿IRRIGATOR¿ASPIRATOR (RIA) SYSTEM TO DETERMINE WHETHER THERE WAS ANY DIFFERENCE IN INTRAOPERATIVE, POSTOPERATIVE, OR PATIENT OUTCOME VARIABLES. BETWEEN APRIL 2008 AND MARCH 2013, 101 ADULT PATIENTS UNDERWENT EITHER ANTEGRADE OR RETROGRADE FEMORAL AUTOLOGOUS BONE GRAFT HARVESTING USING SYNTHES RIA SYSTEM. SEVEN PATIENTS HAD INADEQUATE INTRAOPERATIVE OR POSTOPERATIVE DATA AND WERE EXCLUDED, LEAVING A TOTAL OF 62 ANTEGRADE AND 32 RETROGRADE PROCEDURES. ALL ANTEGRADE RIA BONE GRAFT HARVESTS WERE PERFORMED WITH PIRIFORMIS STARTING PORTALS, WHEREAS RETROGRADE HARVEST GROUP USED THE STANDARD RETROGRADE PORTAL. IN ALL CASES, THE REAMING WAS CONTINUED FOR NEARLY THE FULL LENGTH OF THE FEMUR, ENDING AT THE LEVEL OF THE OPPOSITE METAPHYSIS. THERE WAS, HOWEVER, A SIGNIFICANTLY INCREASED INCIDENCE OF ECCENTRIC REAMING WITHOUT CORTICAL PERFORATION WHEN USING THE PIRIFORMIS PORTAL. ALL 4 FEMURS REQUIRED PROPHYLACTIC INTRAMEDULLARY NAILING BECAUSE OF THE CONCERNS OF A SUBSEQUENT PATHOLOGIC FRACTURE. THE ANTEGRADE GROUP HAD A NONSIGNIFICANT INCREASED INCIDENCE OF HIP PAIN AT THE 6-MONTH FOLLOW-UP VISIT, WHEREAS THE RETROGRADE GROUP HAD A SIGNIFICANTLY HIGHER INCIDENCE OF KNEE PAIN AT THE SAME TIME PERIOD. ALL COMPLAINTS OF HIP OR KNEE PAIN WERE ABSENT BY THE TIME OF FINAL FOLLOW-UP. IN ADDITION, NO CASES OF DELAYED FEMUR FRACTURE, INFECTION, OR ABDUCTOR AND/OR ANTALGIC GAIT INVOLVING THE DONOR EXTREMITY WERE SEEN AT FINAL FOLLOW-UP. THIS REPORT IS FOR AN UNKNOWN REAMER¿IRRIGATOR¿ASPIRATOR (RIA) SYSTEM AND REFERS TO THE INCREASED INCIDENCE OF ECCENTRIC REAMING WITHOUT CORTICAL PERFORATION WHEN USING THE PIRIFORMIS PORTAL WHICH REQUIRED PROPHYLACTIC INTRAMEDULLARY NAILING BECAUSE OF THE CONCERNS OF A SUBSEQUENT PATHOLOGIC FRACTURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786613 REAMER HTO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention