BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5440550 · Received February 17, 2016

    Report

    Report Number
    2520274-2016-11029
    Event Type
    Injury
    Date Received
    February 17, 2016
    Report Date
    January 21, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAHAISAVARIYA, B., KESPRAYURA, S., LAUPATTARAKASEM, W., AND SUTHIYUTH, T. (1992). SUBTROCHANTERIC FRACTURE: FIXATION USING THE AO TIBIAL NAIL. INJURY. 23(4): 231-233. THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT/QUANTITY OF 2. 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. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, MAHAISAVARIYA, B., KESPRAYURA, S., LAUPATTARAKASEM, W., AND SUTHIYUTH, T. (1992). SUBTROCHANTERIC FRACTURE: FIXATION USING THE AO TIBIAL NAIL. INJURY. 23(4): 231-233. FROM DECEMBER 1985 TO NOVEMBER 1989, 24 PATIENTS WITH SUBTROCHANTERIC FRACTURES WERE TREATED BY INTERNAL FIXATION WITH AO TIBIAL NAILS AT (B)(6) HOSPITAL. OF THESE, 22 PATIENTS WERE MALE AND TWO WERE FEMALE. AGES RANGED FROM 14 TO 76 YEARS (AVERAGE 29.6 YEARS). EXCEPT FOR THE TWO PATHOLOGICAL FRACTURES WITH UNDERLYING METASTATIC ADENOCARCINOMA, ALL OTHERS WERE CLOSED FRACTURES RESULTING FROM MOTOR VEHICLE ACCIDENTS. THE AVERAGE DIAMETER OF NAILS USED WAS 12MM (RANGE 11-13 MM). THE NAIL LENGTHS USED IN ALMOST ALL CASES WERE 360MM (RANGE 345-360MM). THERE WERE TWO CASES IN WHICH THE SUPPLEMENTARY SCREWS WERE NOT NECESSARY BECAUSE THE FRACTURE WAS TRANSVERSE AND LOCATED IN THE LOW SUBTROCHANTERIC AREA WITH GOOD APPROXIMATION OF THE BONY SPIKE AT THE FRACTURE END AFTER NAILING. IN TWO PATIENTS WITH PATHOLOGICAL FRACTURES, THE PATIENTS WERE ABLE TO HAVE EARLY POSTOPERATIVE AMBULATION: THERE WERE NO PROBLEMS WITH THE FIXING DEVICES UNTIL THEY DIED 4 AND 7 MONTHS LATER, RESPECTIVELY, FROM ADVANCED MALIGNANT CONDITIONS. A TOTAL OF 18 CASES OF NON-PATHOLOGICAL FRACTURES WERE FOLLOWED UP UNTIL THE FRACTURES WERE HEALED, WITH AN AVERAGE FOLLOW-UP TIME OF 13 MONTHS (RANGE 4-24 MONTHS). THERE WERE TWO CASES IN WHICH THE SUPPLEMENTARY SCREWS BROKE AFTER THE FRACTURE HAD HEALED. THESE WERE CAUSED BY PROXIMAL MIGRATIONS OF THE NAIL. THE NAIL WAS BROKEN AT THE BENDING POINT IN ONE CASE AND HEALED IN A SLIGHTLY VARUS ANGULATION. THERE WAS A CASE THAT HEALED IN AN EXTERNAL ROTATION DEFORMITY OF 10 DEGREES. THIS REPORT IS FOR AN UNKNOWN SCREW AND THE TWO CASES IN WHICH THE SUPPLEMENTARY SCREWS BROKE AFTER THE FRACTURE HAD HEALED. THIS IS REPORT 2 OF 2 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
    98477 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention