BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE 30"(75CM) 5-0 BLK

    MDR report key: 11059667 · Received December 22, 2020

    Report

    Report Number
    2210968-2020-10202
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Report Date
    December 4, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031044548
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 02/08/2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH PDH405, K870W33 AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL SUMMARY: IT WAS RECEIVED FOR ANALYSIS A NEEDLE-SUTURE PIECE AND A SUTURE PIECE AND A SUTURE PIECE OF PRODUCT DURING THE VISUAL INSPECTION OF THE SAMPLES, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE ENDS WERE EXAMINED AND DAMAGED AND STRESS COULD BE OBSERVED. AS WITH ANY DEVICE, CARE SHOULD BE TAKEN TO AVOID DAMAGE TO THE STRAND WHEN HANDLING. AVOID THE CRUSHING OR CRIMPING ACTION OF THE SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS AND FORCEPS. NO CONCLUSION COULD BE REACHED AS ON WHAT CAUSED THE SUTURE STRAND WAS FOUND TO BE BROKEN. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PLEASE CLARIFY HOW THE PROCEDURE WAS COMPLETE? PLEASE PROVIDE PROCEDURE NAME AND DATE? 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

    (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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER PDH405, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING INFORMATION WAS OBTAINED: PLEASE CLARIFY HOW THE PROCEDURE WAS COMPLETE: NO FURTHER INFORMATION IS AVAILABLE. PLEASE PROVIDE PROCEDURE NAME AND DATE: NO FURTHER INFORMATION IS AVAILABLE. STATUS OF PRODUCT RETURN: WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. NO FURTHER INFORMATION WILL BE PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525337 SILK SUTURE 30"(75CM) 5-0 BLK SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. K870H PDH405 10705031044548

    Patients

    Seq Age Sex Outcome Treatment
    1