BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WR 1.2MM X 12 BOX OF 5 STERILE

    MDR report key: 10424714 · Received August 19, 2020

    Report

    Report Number
    1219602-2020-01274
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 28, 2020
    Report Date
    October 5, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010559050
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED 7211138 1.2MMX45CM NITINOL GUIDEWIRE, USED IN TREATMENT, HAS BEEN RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THE GUIDEWIRE BROKE DURING USE. VISUAL ASSESSMENT CONFIRMS BREAKAGE OF GUIDEWIRE. GUIDEWIRE WAS BROKEN IN THREE PLACES. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: EXCESSIVE FORCE PLACED ON THE DEVICE DURING USE. THE INSTRUCTION FOR USE OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE GUIDE TIP BROKE IN TWO DURING THE INSERTION OF THE BIOSURE REGENESORB SCREW. BOTH PIECES WERE SUCCESSFULLY RETRIEVED USING TWEEZERS. THERE WAS A DELAY OF UNDER 30 MIN AND THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892201 GUIDE WR 1.2MM X 12 BOX OF 5 STERILE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 7211138 2044736 03596010559050

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention