BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAIL

    MDR report key: 3709505 · Received March 28, 2014

    Report

    Report Number
    2520274-2014-10510
    Event Type
    Injury
    Date Received
    March 28, 2014
    Report Date
    March 17, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 3 UNKNOWN NAILS/UNKNOWN LOT NUMBERS. 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: INTRAMEDULLARY NAILING WITHOUT INTERLOCKING SCREWS FOR FEMORAL AND TIBIAL SHAFT FRACTURES. KREB, D., ET AL (2013) ARCH ORTHOP TRAUMA SURG, 133: 1109-1113. A RETROSPECTIVE ANALYSIS WAS PERFORMED OF ALL PATIENTS TREATED BETWEEN OCTOBER 2003 AND AUGUST 2009. 29 LONG BONE ACUTE TRAUMATIC DIAPHYSEAL TIBIAL OR FEMUR FRACTURES WERE TREATED IN 27 PATIENTS (20 MEN AND 7 WOMEN) WITH AN AVERAGE AGE OF 28.9 YEARS OLD (RANGE 15.6-54.4). THE UNREAMED FEMUR NAIL (UFN, SYNTHES BV, ZEIST, THE NETHERLANDS) WAS USED FOR ALL FEMORAL FRACTURES (9 MILLIMETER: N = 9, 10 MILLIMETER: N=3). THIRTEEN TIBIAL FRACTURES WERE STABILIZED WITH AN UNREAMED TIBIA NAIL (UTN, SYNTHES BV, ZEIST, THE NETHERLANDS), 8 MILLIMETER: N=9, 9 MILLIMETER: N=5. THE EXPERT TIBIA NAIL (ETN, SYNTHES BV, ZEIST, THE NETHERLANDS, 8 MILLIMETER) WAS USED FOR THE REMAINING FOUR. SUBSEQUENTLY, THREE PATIENTS DEVELOPED COMPARTMENT SYNDROME WHICH REQUIRED FASCIOTOMY, ONE OF WHICH WAS CARRIED OUT IMMEDIATELY AFTER INSERTION OF NAIL. ONE PATIENT HAD DELAYED UNION IN ONE TIBIAL FRACTURE, WITH 31 WEEKS TO CONSOLIDATION. ALL PATIENTS RETURNED TO THEIR PRE-INJURY LEVEL OF ACTIVITY. ONE TIBIAL FRACTURE WAS CONVERTED TO A STANDARD LOCKED NAIL 18 DAYS AFTER THE INITIAL INSERTION OF THE INTRAMEDULLARY NAIL BECAUSE OF AXIAL AND ROTATIONAL INSTABILITY. SIX MONTHS AFTER THE INITIAL TRAUMA, THE NAIL WAS EXCHANGED FOR A LARGER (11 MILLIMETER) CANNULATED INTERLOCKED NAIL BECAUSE OF FAILURE OF PROGRESSION OF FRACTURE HEALING. THIS WAS COMPLICATED BY INFECTION OF THE PROXIMAL INTERLOCKING SCREW, WHICH WAS REMOVED AFTER FIVE WEEKS. FURTHER HEALING WAS UNEVENTFUL. TOTAL HEALING TIME FOR THIS PATIENT WAS 38 WEEKS. THREE TIBIA NAILS WERE REMOVED BECAUSE OF ANTERIOR KNEE PAIN. IN ONE OF THESE PATIENTS THE PAIN WAS DUE TO SECONDARY NAIL PROTRUSION INTO THE KNEE JOINT. IN TWO PATIENTS NAIL REMOVAL RESOLVED THE COMPLAINTS. TWO TIBIA NAILS WERE REMOVED IN ACCORDANCE WITH THE PATIENTS REQUEST. IN ONE PATIENT THIS LED TO MORE KNEE PAIN POSTOPERATIVELY. ALL PATIENTS RETURNED TO THEIR PRE-INJURY LEVEL OF ACTIVITY. IT WAS CONCLUDED THAT THE USE OF INTRAMEDULLARY NAILING WITHOUT INTERLOCKING IS ASSOCIATED WITH MINIMAL COMPLICATIONS IN SELECTED FRACTURES. THE ADVANTAGES INCLUDE A SHORT OPERATING TIME AND THE SIMPLICITY OF ITS APPLICATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN NAIL. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS COMPLAINT INVOLVES 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184499 UNK - NAIL NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention