BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5398538 · Received January 29, 2016

    Report

    Report Number
    2520274-2016-10535
    Event Type
    Injury
    Date Received
    January 29, 2016
    Date of Event
    March 28, 2006
    Report Date
    January 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. BAE, S., JUNG, D., OH, C., OH, J. TREATMENT OF OPEN TIBIAL SHAFT FRACTURES USING TIGHTLY FITTED INTERLOCKING NAILING (2006) INTERNATIONAL ORTHOPAEDICS, 30: 333¿337. (B)(4). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE PROVIDED. 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

    DATE OF EVENT: (B)(6) 2006. 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: BAE, S., JUNG, D., OH, C., OH, J. TREATMENT OF OPEN TIBIAL SHAFT FRACTURES USING TIGHTLY FITTED INTERLOCKING NAILING (2006) INTERNATIONAL ORTHOPAEDICS, 30: 333-337. THIS ARTICLE DESCRIBES THE RESULTS OF TREATING OPEN TIBIAL SHAFT FRACTURES WITH TIGHTLY FITTED NAILING AFTER MINIMAL HAND REAMING IN ORDER TO MINIMIZE OSTEONECROSIS DUE TO VASCULAR DAMAGE, AND TO AVOID METAL FAILURES AND DELAYED UNIONS. 23 PATIENTS WERE INCLUDED IN THIS STUDY BETWEEN JANUARY 2000 THROUGH DECEMBER 2003. THE STUDY GROUP INCLUDED 21 MEN AND 2 WOMEN WITH AN AVERAGE AGE OF 38.6. IN EIGHT CASES IN WHICH A SECONDARY PROCEDURE WAS NECESSARY FOR BONE UNION, THE TIME FOR UNION WAS 10.2 MONTHS ON AVERAGE. IN THE REMAINING ONE CASE, BONE UNION WAS OBTAINED AT 9 MONTHS WITH BONE TRANSPORT BECAUSE OF A DEEP INFECTION (CASE 18). OF EIGHT CASES (CASES 1, 2, 5, 7, 13, 14, 15, 17) THAT NEEDED A SECONDARY PROCEDURE FOR BONE UNION, ONE CASE IN WHICH EARLY DYNAMIC FIXATION WAS PERFORMED UNDERWENT EXCHANGE NAILING AT 5.5 MONTHS AND BONE UNION WAS OBTAINED IN 6 MONTHS (CASE 1). SIX CASES (CASES 2, 5, 7, 13, 15, 17) OF EARLY STATIC FIXATION RESULTING IN DELAYED UNION UNDERWENT DYNAMISATION AT 2-5 MONTHS AND FOUR CASES UNITED WITHOUT FURTHER PROCEDURE. TWO CASES THAT WERE NOT UNITED AFTER DYNAMISATION UNDERWENT EXCHANGE NAILING. AFTER EXCHANGE, ONE CASE UNITED IN 5 MONTHS (CASE 17) AND THE OTHER WAS DIAGNOSED AS NON-UNION BECAUSE THE ANTEROLATERAL BONE DEFECT WAS NOT FILLED WITH CALLUS, ALTHOUGH THE POSTERIOR CORTEX WAS CONNECTED WITH CALLUS FORMATION 6 MONTHS AFTER EXCHANGE. INTERLOCKING SCREW BREAKAGE WAS NOTED IN ONE CASE (CASE 7) IN WHICH A LARGE DIAMETER IM NAIL, 12 MM, HAD BEEN USED. THE NAIL WAS DYNAMISED AT 2 MONTHS. A SCREW INSERTED IN THE PROXIMAL OVAL LOCKING HOLE HAD BROKEN. DESPITE THIS METAL FAILURE, BONE UNION WAS OBTAINED 12 MONTHS AFTER DYNAMISATION. A (B)(6)-YEAR-OLD POLYTRAUMATISED PATIENT DEVELOPED DEEP INFECTION 7 DAYS AFTER SOFT TISSUE COVERAGE. THE NAIL WAS REMOVED, THE TIBIA WAS SHORTENED BY 6 CM IN ORDER TO CLOSE THE SOFT TISSUE DEFECT, AND THE FRACTURE WAS SECURED USING A RING EXTERNAL FIXATOR. A RESTRICTED RANGE OF MOTION WAS OBSERVED IN FIVE CASES (CASES 1, 7, 13, 16, 18). TWO OF THE FIVE RESTRICTED RANGE OF MOTION CASES (CASES 1, 16) HAD COEXISTING BRAIN DAMAGE. IN THE OTHER TWO CASES (CASES 7, 18), REPEATED DEBRIDEMENTS WERE INEVITABLE DUE TO SEVERE MUSCULAR INJURIES. THIS REPORT IS FOR AN UNKNOWN UNTN UNIVERSAL TIBIAL NAIL. (B)(4). THIS MEDWATCH PERTAINS TO CASE 18: (B)(6) YEAR OLD PATIENT EXPERIENCED DEEP INFECTION IN WHICH THE NAIL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57373 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention