BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STLESS STEEL SIL 4X18IN 7 S/A CCS

    MDR report key: 21809478 · Received April 9, 2025

    Report

    Report Number
    2210968-2025-03850
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 10, 2025
    Report Date
    June 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE CUSTOMER JUST PULLED ALL THE PRODUCT REGARDLESS OF LOT NUMBER AT THAT POINT. YOU MAY DISCARD.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/8/2025. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION: D9, H3, H6. THE FOLLOWING INFORMATION WAS RECEIVED: ANECDOTALLY, ALL SCRUB NURSES ARE REPORTING NEEDLES DETACHING FROM THE WIRE (NOT ALL, BUT AT LEAST 1-2 FROM A PACK). IT LOOKS LIKE THE NEEDLE IS NOT CRIMPED PROPERLY ONTO THE WIRE. UNFORTUNATELY WE ARE NOT ABLE TO SAVE ANY OF THE AFFECT WIRES, THE SURGEONS ARE JUST TRYING ANOTHER WIRE TO GET THROUGH THE STERNUM. A DEVICE HAS BEEN RECEIVED, HOWEVER CLARIFICATION IS REQUESTED WHETHER THE PRODUCT BELONGS TO THIS COMPLAINT. THE FOLLOWING INFORMATION WAS REQUESTED: PRODUCT CODE M655 LOT 104XHK. 1. PLEASE CLARIFY IF THE ADDITIONAL DEVICE BELONG TO THIS COMPLAINT? 1A. IF YES, DID A DEVICE MALFUNCTION OCCUR DURING THE SAME PROCEDURE? 2. IF NOT, PLEASE CLARIFY IF THE ADDITIONAL RECEIVED PRODUCT BELONGS TO A DIFFERENT COMPLAINT? IF SO, CAN YOU PLEASE PROVIDE THE COMPLAINT NUMBER. 3. IF THE DEVICE WAS NOT REPORTED BEFORE, PLEASE PROVIDE MORE DETAILS OF DEVICE MALFUNCTION. 4. IF THE PRODUCT DOESN¿T BELONG TO ANY COMPLAINT, PLEASE LET US KNOW SO WE CAN DISCARD IT OR ADVISE IF THE PRODUCT IS REQUIRED TO BE RETURNED. 5. IF YOU HAVE THE CORRECT COMPLAINT PRODUCT IN YOUR POSSESSION, PLEASE FORWARD THE PRODUCT TO ETHICON AS SOON AS POSSIBLE. IF YOU HAVE ALREADY SENT THE PRODUCT TO ETHICON, PLEASE REPLY TO [email protected] WITH THE UPS, DHL OR FEDEX TRACKER NUMBER. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. SIXTY-FOUR REPRESENTATIVE UNOPENED SAMPLES EACH AND ONE OPEN BOX WITH TEN REPRESENTATIVE UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. PRODUCT CODE M655G, LOT 105P5R. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. UPON INITIAL INSPECTION OF THE SAMPLES, NO EXTERNAL DAMAGES WERE EVIDENT ON THE EXTERIOR PACKAGING. FOLLOWING THE SAMPLING PLAN, A VISUAL INSPECTION WAS CONDUCTED ON THIRTEEN SAMPLES. THE SWAGE AND ATTACHMENT AREAS APPEARED AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED AND NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE PULL FORCE RESULT WAS ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/9/2025. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING INFORMATION WAS RECEIVED: UNUSED SUTURES PULLED AND SENDING IN. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: (B)(4): INITIAL REPORTING FOR "SURGEONS COMPLAINING THAT THE NEEDLE POPS OFF AFTER MAKING ONE PASS THROUGH..." (B)(4): FILE TO CAPTURED THE MULTIPLE EVENTS REPORT. PLEASE CONFIRM THE NUMBER OF PATIENTS AFFECTED BY THIS ALLEGED DEFICIENCY. HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). IF NO, PLEASE CREATE A NEW PC FILE FOR EACH PATIENT/EVENT. PLEASE PROVIDE INFORMATION REQUESTED BELOW FOR EACH PATIENT/EVENT. HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? PLEASE CONFIRM IF THE DEVICES ARE AVAILABLE FOR PRODUCT RETURN. IF YES, CONFIRM THE QUANTITY OF DEVICES AVAILABLE FOR PRODUCT ANALYSIS AND PROVIDE THE STATUS OF THE DEVICES AS THEY HAVE NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). AFTER VARIOUS ATTEMPTS TO GET FURTHER INFORMATION, THEY HAVE NOT PROVIDED ANY. I HAVE THE UNUSED PACKAGES AND WILL RETURN. 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 SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEONS ARE COMPLAINING THAT THE NEEDLE POPS OFF AFTER MAKING ONE PASS THROUGH. NO OTHER DETAILS AND THE SUTURE WAS NOT SAVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453489 STLESS STEEL SIL 4X18IN 7 S/A CCS SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. 105P5R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown