BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 30IN USP4-0

    MDR report key: 11356878 · Received February 21, 2021

    Report

    Report Number
    2210968-2021-01626
    Event Type
    Malfunction
    Date Received
    February 21, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031100770
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 06/09/2021. ADDITIONAL H6 COMPONENT CODE: G07002 ¿ CONFORMING DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH PBQ793, K942H55 AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL H-3 SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT SEVENTEEN UNOPENED SAMPLES OF PRODUCT CODE J494 WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF UNOPENED SAMPLES AND NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS OR DAMAGED WERE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED AND THE PULL FORCE WERE ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED AND THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. 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. DATE SENT TO THE FDA: 06/09/2021. 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 · 1

    PRODUCT COMPLAINT # (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DID THE PATIENT EXPERIENCE ANY ADVERSE CONSEQUENCES DUE TO THIS ISSUE? NOT REPORTED. PLEASE PROVIDE PROCEDURE DATE? UNKNOWN. WHAT IS THE STATUS OF THE RETURN SAMPLES? DISTRIBUTOR WILL RETURN SOME SAMPLES FROM THE SAME BOX NOT USED IN PROCEDURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. INTRA-OPERATIVELY THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253702 SILK BLK 30IN USP4-0 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. K942H PBQ793 10705031100770

    Patients

    Seq Age Sex Outcome Treatment
    1