BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BRD BLK 15X60CM M2.5

    MDR report key: 12615946 · Received October 12, 2021

    Report

    Report Number
    2210968-2021-09547
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 5, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 11/24/2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ADDITIONAL H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. ADDITIONAL H-3 SUMMARY: ACTUAL CUSTOMER COMPLAINT SAMPLE OR SAME BATCH REPRESENTATIVE SAMPLE ARE NOT RETURNED. SAME BATCH MANUFACTURER RETAINED SAMPLE EVALUATED FOR APPEARANCE AND TENSILE STRENGTH AND NO ISSUE FOUND. DHR REVIEWED AND NO ISSUE FOUND. THE ROOT CAUSE OF THIS COMPLAINT CAN¿T BE DETERMINED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: COULD YOU PLEASE CONFIRM IF THE PATIENT SUFFER FROM ANY CONSEQUENCE DUE TO THE ISSUE (BREAKAGE SUTURE)? IF YES, ALL ANSWERS ABOVE ARE UNOBTAINABLE. ONCE THERE IS ANY UPDATE, WE WILL UPDATE THE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF PHALANX FRACTURE DUE TO RIGHT TOE FRACTURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WHEN SEWING THE SKIN AT TIME OF KNOTTING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510104 SILK BRD BLK 15X60CM M2.5 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. QJ5AG

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male