BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ILIZAROV EXFIX DEVICE

    MDR report key: 10028718 · Received May 6, 2020

    Report

    Report Number
    1020279-2020-01487
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    April 15, 2020
    Report Date
    September 8, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: IT WAS REPORTED FROM A LITERATURE REVIEW THAT WITHIN THE FIRST 2 WEEKS OF TREATMENT, THE TRANSPORT WIRE PULLED THROUGH THE OSTEOPENIC BONE, NECESSITATING REVISION. THE AFFECTED COMPLAINT DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE A PRODUCT ANALYSIS COULD NOT BE PERFORMED. AS DEVICE INFORMATION WAS NOT MADE AVAILABLE, DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW CANNOT BE COMPLETED. THERE IS NO INFORMATION THAT WOULD SUGGEST THE DEVICE FAILED TO MEET SPECIFICATIONS. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CORROBORATED. NO MEDICAL DOCUMENTS WERE RECEIVED FOR INVESTIGATION. THEREFORE NO MEDICAL ASSESSMENT CAN BE PERFORMED AT THIS TIME. SOME POTENTIAL CAUSES OF THE REPORTED EVENT COULD INCLUDE BUT NOT LIMITED TO SURGICAL TECHNIQUE USED OR USER/PROCEDURAL VARIANCE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED AND NO PATIENT MEDICAL RECORDS AVAILABLE, OUR INVESTIGATION OF THIS REPORT IS INCONCLUSIVE. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    "INTERNAL BONE TRANSPORT USING A CANNULATED SCREW AS A MOUNTING DEVICE IN THE TREATMENT OF A POST-INFECTIVE ULNAR DEFECT". AUTHOR: KONSTANTINOS TSITSKARIS ET AL., 2016 11:63¿67. IN THIS STUDY, IT WAS REPORTED A CASE OF A SEGMENTAL ULNAR BONE DEFECT IN A YOUNG CHILD TREATED WITH INTERNAL BONE TRANSPORT USING A CANNULATED SCREW AS THE MOUNTING DEVICE. ACCORDING TO THE PAPER, THIS TECHNIQUE WAS FOUND TO BE PARTICULARLY USEFUL IN THE TREATMENT OF BONE LOSS SECONDARY TO INFECTION, WHERE PREVIOUS TREATMENT AND PROLONGED IMMOBILISATION HAD LED TO OSTEOPENIA. THIS TECHNIQUE HAS NOT BEEN PREVIOUSLY REPORTED. IT WAS DOCUMENTED ON THE PAPER THAT A AN ILIZAROV FIXATOR (SMITH & NEPHEW ORTHOPAEDICS (B)(4)) WAS USED. WITHIN THE FIRST 2 WEEKS OF TREATMENT, THE TRANSPORT WIRE PULLED THROUGH THE OSTEOPENIC BONE, NECESSITATING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494028 UNKNOWN ILIZAROV EXFIX DEVICE PIN, FIXATION, THREADED JDW SMITH & NEPHEW, INC. UNKNOWN ILIZAROV EXFIX DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R