BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAMER

    MDR report key: 7483289 · Received May 3, 2018

    Report

    Report Number
    2939274-2018-51993
    Event Type
    Injury
    Date Received
    May 3, 2018
    Report Date
    April 6, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, DATE OF BIRTH, AND WEIGHT NOT AVAILABLE FOR REPORTING. THE 510K: THIS REPORT IS FOR AN UNKNOWN REAMER/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING LITERATURE ARTICLE: WATERMAN, B., DAVEY, S., KANLIC, E., & ABDELGAWAD, A. (2017). INTRAMEDULLARY BONE GRAFT HARVEST USING REAMER-IRRIGATOR-ASPIRATOR SYSTEM: A CASE SERIES. JOURNAL OF SURGICAL ORTHOPAEDIC ADVANCES, 26(4), 233-238. USA. THIS STUDY WAS CONDUCTED TO EVALUATE THE EFFICACY AND COMPLICATIONS PERTAINING TO USE OF INTRAMEDULLARY (IM) BONE GRAFT HARVESTING TECHNIQUE USING REAMER-IRRIGATOR-ASPIRATOR (RIA,; SYNTHES, PAOLI, PENNSYLVANIA) TECHNIQUE ALONG WITH THE CLINICAL RESULTS OF NONUNIONS AND BONE DEFECTS TREATED WITH THIS GRAFT SOURCE. THE STUDY INCLUDED PATIENTS WITH PLANNED IM BONE GRAFT HARVESTING FOR THE SECONDARY TREATMENT OF NONUNION, DELAYED HEALING OR SIGNIFICANT BONE DEFECT DURING THE YEARS 2009 THROUGH 2012. THE BONE GRAFTS GENERATED FROM THE ENTRY REAMER WERE REMOVED FROM THE FLUTES AND LATER ADDED TO THE NONUNION SITE. TWENTY-FOUR (24) RIA PROCEDURES WERE PERFORMED IN TWENTY-THREE (23) CONSECUTIVE PATIENTS WITH EXTREMITY NONUNIONS DURING THE SAID PERIOD. OF THESE, FOURTEEN (14) PATIENTS WERE MALES. MEAN AGE OF THESE PATIENTS WAS RECORDED TO BE THIRTY-NIN (39) YEARS, THE RANGE BEING 15-66 YEARS. THREE INTRA-OPERATIVE COMPLICATIONS WERE OBSERVED WHILE USING THE RIA GRAFTING TECHNIQUE. THESE ARE AS FOLLOWS: PATIENT 1 ¿ ONE (1) SIXTY-SIX (66) YEARS OLD FEMALE PATIENT HAD A GUNSHOT-RELATED GRADE IIIC OPEN HUMERAL SHAFT FRACTURE TREATED WITH EXTERNAL FIXATION THAT LED TO DELAYED HEALING. THIS PATIENT UNDERWENT TIBIAL RIA. DURING THE PROCEDURE, SURGEONS NOTICED THE REAMING TO BE ECCENTRIC, RESULTING IN MARKED THINNING OF THE POSTEROMEDIAL CORTEX. THE PROCEDURE WAS ABORTED JUST DISTAL TO THE MIDDLE OF THE TIBIA TO AVOID INTRAOPERATIVE FRACTURE DUE TO THE ECCENTRIC REAMING. PATIENT 2 - THE SECOND PATIENT WAS A 22-YEAR OLD MALE WITH A GRADE IIIB PROXIMAL TIBIAL NONUNION AND SEGMENTAL BONE LOSS WHO UNDERWENT BILATERAL FEMORAL RIA TO OBTAIN SUFFICIENT BONE GRAFT. FOUR MONTHS LATER, THE PATIENT SUSTAINED A SPIRAL DISTAL FEMORAL SHAFT FRACTURE DURING A FALL FROM A STANDING HEIGHT (FIG. 2), WHICH REQUIRED OPEN REDUCTION AND INTERNAL FIXATION. PATIENT 3 ¿ ONE (1) FORTY-FIVE (45) YEAR OLD MALE PATIENT WITH A IIIB OPEN PROXIMAL TIBIA AND TIBIAL SHAFT FRACTURE FAILED PREVIOUS TREATMENTS DUE TO PERSISTENT NONUNIONS, AND SUBSEQUENTLY WAS UNDERWENT AN ANTEGRADE FEMORAL HARVEST. DURING THIS ATTEMPTED ANTEGRADE FEMORAL HARVEST, THE REAMER BROKE AT THE JUNCTION OF THE REAMER SHAFT AND THE REAMER HEAD WITH RETENTION OF METAL DEBRIS IN THE PROXIMAL FEMUR. THIS REPORT ADDRESSES PATIENT 2. THIS IS REPORT 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328294 REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention