BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 4723813 · Received April 23, 2015

    Report

    Report Number
    2520274-2015-13342
    Event Type
    Injury
    Date Received
    April 23, 2015
    Report Date
    March 31, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 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. (B)(4). THIS REPORT IS FOR AN UNKNOWN NAIL. 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. 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, FERNANDES HJA, SAKAKI MH, SILVA JS, REIS FB, AND ZUMIOTTI AV. (2006). COMPARATIVE MULTICENTER STUDY OF TREATMENT OF MULTI-FRAGMENTED TIBIAL DIAPHYSEAL FRACTURES WITH NONREAMED INTERLOCKING NAILS AND WITH BRIDGING PLATES. CLINICS. 61(4):333-338. THIS WAS A PROSPECTIVE, RANDOMIZED STUDY TO COMPARE PATIENTS WITH CLOSED, MULTI-FRAGMENTED TIBIAL DIAPHYSEAL FRACTURES TREATED USING ONE OF TWO FIXATION METHODS UNDERTAKEN DURING MINIMALLY INVASIVE SURGERY: NONREAMED INTERLOCKING INTRAMEDULLARY NAILS OR BRIDGING PLATES. FORTY-FIVE PATIENTS WERE STUDIED; 22 PATIENTS WERE TREATED WITH BRIDGING PLATES, 23 WITH INTERLOCKING NAILS WITHOUT REAMING. THE STUDY PERIOD WAS FROM (B)(6) 2002 TO (B)(4) 2003. THE FOLLOW-UP PERIOD VARIED BETWEEN 6 MONTHS TO ONE YEAR. THE BLOCKED INTRAMEDULLARY NAILS USED WERE SYNTHES (B)(4) UNIVERSAL STEEL NAILS INTRODUCED WITH NO MEDULLARY CHANNEL REAMING. THE AUTHORS USED A NARROW PLATE FOR LARGE FRAGMENTS (4.5 MM SYNTHES (B)(4)). IN THE GROUP TREATED WITH INTRAMEDULLARY NAILS, 4 PATIENTS WERE WOMEN AND 19 WERE MEN, WHILE IN THE GROUP TREATED WITH A BRIDGING PLATE, 3 WERE WOMEN AND 19 WERE MEN. THE HEALING TIME FOR PATIENTS WHO RECEIVED NAILS WAS SIGNIFICANTLY LONGER, BY AN AVERAGE OF 4.30 WEEKS, THAN THE HEALING TIME FOR THOSE WHO RECEIVED BRIDGING PLATES. FOUR PATIENTS (NUMBERS 1, 3, 7, AND 8) WHO WERE TREATED WITH INTRAMEDULLARY NAILS EXPERIENCED DELAYED HEALING. THIS REPORT IS FOR AN UNKNOWN NAIL. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4). THIS MEDWATCH PERTAINS TO PATIENT NUMBER 1 WHO EXPERIENCED DELAYED HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270468 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention