BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3915796 · Received July 7, 2014

    Report

    Report Number
    2520274-2014-11883
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    June 11, 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

    MAHAJAN, V., CHUNG, H., SUH, J., (2011), FRACTURES OF THE PROXIMAL FIFTH METATARSAL: PERCUTANEOUS BICORTICAL FIXATION, CLINICS IN ORTHOPEDIC SURGERY, 3, 140-146. THIS REPORT IS FOR AN UNKNOWN CANNULATED SCREW. 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: MAHAJAN, V., CHUNG, H., SUH, J., (2011), FRACTURES OF THE PROXIMAL FIFTH METATARSAL: PERCUTANEOUS BICORTICAL FIXATION, CLINICS IN ORTHOPEDIC SURGERY, 3, 140-146. IN THIS ARTICLE THE AUTHOR LOOKED AT DISPLACED INTRA-ARTICULAR ZONE I AND DISPLACED ZONE II FRACTURES OF THE PROXIMAL FIFTH METATARSAL BONE AND THEIR FREQUENCY OF COMPLICATION BY DELAYED NONUNION DUE TO A VASCULAR WATERSHED. BETWEEN JANUARY 2003 AND AUGUST 2008 TWENTY THREE PATIENTS WERE TREATED FOR THE FRACTURES WITH A 4.0MM CANNULATED TITANIUM SCREW. ALL THE FRACTURES WERE EVALUATED BOTH CLINICALLY AND RADIOLOGICALLY FOR THE HEALING. ALL THE PATIENTS WERE FOLLOWED AT TWO OR THREE WEEK INTERVALS TILL FRACTURE UNION. THE PATIENTS WERE FOLLOWED FOR AN AVERAGE OF 22.5 MONTHS. THE ONLY COMPLICATION WAS ONE PATIENT HAD A NON-UNION THAT REQUIRED REVISION SURGERY. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT INVOLVES AN UNKNOWN CANNULATED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394061 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention