BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3919644 · Received July 8, 2014

    Report

    Report Number
    2520274-2014-12145
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    June 13, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THOMAS, J., DAVIS, B. TREATMENT OF JONES FRACTURE NONUNION WITH ISOLATED INTRAMEDULLARY SCREW FIXATION. THE JOURNAL OF FOOT & ANKLE SURGERY 50 (2011) 566-568. THIS REPORT IS FOR AN UNKNOWN INTRAMEDULLARY SCREW FIXATION. 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: THOMAS, J., DAVIS, B. TREATMENT OF JONES FRACTURE NONUNION WITH ISOLATED INTRAMEDULLARY SCREW FIXATION. THE JOURNAL OF FOOT & ANKLE SURGERY 50 (2011) 566-568. A RETROSPECTIVE CASE SERIES OF SEVEN PATIENTS (1 MALE AND 6 FEMALE), AVERAGE 44.8 YEARS (39-54 YEARS) WHO WERE INITIALLY TREATED NONOPERATIVELY FOR ACUTE FIFTH METATARSAL FRACTURES. THEY DEVELOPED NONUNION AND WERE TREATED WITH INTRAMEDULLARY SCREW FIXATION WITHOUT EXPOSURE, DEBRIDEMENT, BONE GRAFTING, OR THE USE OF OTHER ORTHOBIOLOGIC AGENTS. SCREW INSERTION WAS PERFORMED THROUGH A 1.5-CM INCISION AT THE BASE OF THE FIFTH METATARSAL. A SYNTHES NONCANNULATED SCREW SYSTEM WAS USED IN ALL PATIENTS. FIVE 4.5-MM DIAMETER AND TWO 5.5-MM DIAMETER STAINLESS STEEL SCREWS. ALL DEMONSTRATED RADIOGRAPHIC HEALING BY 11 WEEKS POSTOPERATIVELY. ONLY ONE SCREW WAS REMOVED SECONDARY TO IRRITATION FROM A PROMINENT SCREW HEAD. IT WAS NOT REPORTED WHICH GAUGE SCREW WAS REMOVED. THIS REPORT IS FOR UNKNOWN INTERMEDULLARY SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397606 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention