BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3749590 · Received April 14, 2014

    Report

    Report Number
    2520274-2014-10754
    Event Type
    Injury
    Date Received
    April 14, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DELEANU, B., PREJBEANU, R., POENARU, D., VERMESAN, D., AND HARAGUS, H. (2013). REAMED VERSUS UNREAMED INTRAMEDULLARY LOCKED NAILING IN TIBIAL FRACTURES. EUR J ORTHOP SURG TRAUMATOL. DOI 10.1007/S00590-013-1401-0. THIS REPORT IS FOR AN UNKNOWN NAIL. IMPLANT, EXPLANT DATED: DATES UNKNOWN. 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. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, DELEANU, B., PREJBEANU, R., POENARU, D., VERMESAN, D., AND HARAGUS, H. (2013). REAMED VERSUS UNREAMED INTRAMEDULLARY LOCKED NAILING IN TIBIAL FRACTURES. EUR J ORTHOP SURG TRAUMATOL. DOI 10.1007/S00590-013-1401-0. THE AUTHORS CONDUCTED A PROSPECTIVE OBSERVATIONAL STUDY TO IDENTIFY IF REAMING OF TIBIAL SHAFT FRACTURES HAD BENEFITS OVER UNREAMED INTRAMEDULLARY LOCKED NAILING. EIGHTY FOUR PATIENTS WITH TIBIAL SHAFT FRACTURES WERE TREATED WITH REAMED (41 PATIENTS; 22 FEMALES) OR UNREAMED (43 PATIENTS; 19 FEMALES) INTRAMEDULLARY LOCKED NAIL FIXATION. FOLLOW-UP WAS 12 MONTHS. THE MAJORITY OF CASES IN THE UNREAMED GROUP (32 OUT OF 43) WERE OPERATED ON USING SYNTHES TITANIUM FULL NAILS. MOST PATIENTS IN THE REAMED GROUP (35 OUT OF 41) WERE OPERATED ON USING SYNTHES STAINLESS STEEL HOLLOW NAILS AND DEVICE OF COMPETITOR. THE AUTHORS REPORTED: TWO CASES OF NONUNION, ONE IN EACH GROUP, TREATED BY EXCHANGE NAILING AND AUTOLOGOUS BONE GRAFTING; SEVEN PATIENTS DEMONSTRATED CLINICAL HEALING WITHOUT RADIOLOGICAL HEALING (THREE IN REAMED GROUP, FOUR IN UNREAMED GROUP). IN ADDITION, SIXTEEN PATIENTS HAD THEIR NAILS REMOVED. THE MAIN COMPLAINT (TEN PATIENTS) WAS LATERAL ANKLE PAIN DUE TO DISTAL SCREW IMPINGEMENT. THE AUTHORS CONCLUDED THAT REAMED NAILING WAS BENEFICIAL; HOWEVER, THE IMPACT ON OVERALL OUTCOME WAS NOT SUPERIOR TO UNREAMED NAILING. PATIENTS WERE IMPLANTED WITH SYNTHES TITANIUM FULL NAILS AND STAINLESS STEEL HOLLOW NAILS AND DEVICES OF OTHER MANUFACTURERS. THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHICH DEVICE OF THE MANUFACTURERS WAS ASSOCIATED WITH EACH PATIENT; THEREFORE, THIS MEDWATCH IS BEING SUBMITTED FOR THE EVENT. THIS REPORT IS FOR AN UNKNOWN NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226677 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention