BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL FIXATOR PIN

    MDR report key: 10045502 · Received May 11, 2020

    Report

    Report Number
    1020279-2020-01593
    Event Type
    Injury
    Date Received
    May 11, 2020
    Report Date
    October 1, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED FROM A LITERATURE REVIEW THAT THE PATIENT PRESENTED PIN SITE INFECTION WHICH WAS TREATED BY LOCAL WOUND CARE INCLUDING RELAXING SKIN INCISIONS UNDER LOCAL ANESTHESIA, DEBRIDEMENT AND PARENTAL ADMINISTRATION OF CEFAZOLIN. 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, STERILIZATION DOCUMENTATION 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. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE PAPER WAS PUBLISHED IN 2014. INFECTION, A POTENTIAL COMPLICATION ASSOCIATED WITH ANY SURGERY, CAN OCCUR AND POSSIBLE CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO CONTAMINATION, PATIENT REACTION, AND POST-OPERATIVE HEALING ISSUE. 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

    "ARTHRODESIS WITH THE ILIZAROV DEVICE AFTER FAILED KNEE ARTHROPLASTY". AUTHOR: RAMI DAVID, MD ET AL., ORTHO BLUE JOURNAL, 2001. ACCORDING TO THE STUDY, THIRTEEN PATIENTS WITH FAILED TOTAL KNEE ARTHROPLASTY (TKA) DUE TO INFECTION (12 PATIENTS) OR ASEPTIC LOOSENING (1 PATIENT) UNDERWENT ARTHRODESIS USING AN SMITH AND NEPHEW ILIZAROV EXTERNAL FIXATOR. IT WAS DOCUMENTED THAT ONE PATIENT HAD PIN TRACK INFECTION, IT WAS SUCCESSFULLY TREATED BY LOCAL WOUND CARE INCLUDING RELAXING SKIN INCISIONS UNDER LOCAL ANESTHESIA, DEBRIDEMENT AND PARENTAL ADMINISTRATION OF CEFAZOLIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507981 UNKNOWN EXTERNAL FIXATOR PIN PIN, FIXATION, THREADED JDW SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R