BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHLN BLK 6IN 9-0 S/A BV100-4

    MDR report key: 18248220 · Received December 1, 2023

    Report

    Report Number
    2210968-2023-09385
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    September 26, 2023
    Report Date
    January 18, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED, FOUR UNOPENED SAMPLES THAT PERTAIN TO THE PRODUCT CODE EH7448G. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND NO ANOMALIES WERE OBSERVED DURING THE 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. 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). 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED 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: WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? OPEN DOES THE PIECE/DEVICE REMAIN RETAINED IN THE PATIENT'S TISSUE? YES IF THE PIECE(S) WERE RETAINED, WHERE ARE THEY LOCATED/IN WHAT STRUCTURE? NECK AREA IF RETAINED, ARE THERE PLANS FOR REMOVAL OF ANY REMAINING FRAGMENTS? NO WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? THE SURGEON DID NOT CONSIDER THE TINY REMAINING FRAGMENT TO BE TOO CRITICAL THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DESPITE REPEATED REQUESTS,SALES REP DID NOT RECEIVE ANY INFORMATION ABOUT THE PATIENT. SPECIFIC SURGERY OR PATIENT DATA COULD NO LONGER BE TRACED ACCORDING TO THE SURGERY. ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? WHERE WAS THE NEEDLE GRASPED DURING USE? WERE X-RAYS PERFORMED TO LOCALIZE THE NEEDLE FRAGMENT? IF RETAINED, WERE THERE ANY PATIENT CONSEQUENCES? IF A SURGERY IS PLANNED, PLEASE PROVIDE A DATE. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PATIENT'S CURRENT STATUS? IF APPLICABLE, WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. SURGEON¿S NAME? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR OROPHARYNGEAL CARCINOMA WITH RADIALIS FLAP ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE PULLED OFF DURING USE. THE LOST NEEDLE COULD NOT BE FOUND OR RETRIEVED AND HAD PROBABLY REMAINED IN THE PATIENT, IN THE NECK AREA. HOWEVER, THE SURGEON DID NOT CONSIDER THE SITUATION TO BE TOO DRAMATIC, AS IT WAS A VERY SMALL, VERY THIN 5 MM NEEDLE. NO COMPLICATIONS HAVE YET OCCURRED IN THE PATIENT CONCERNED. NO SPECIFIC DATE FOR THE OPERATION HAVE BEEN GIVEN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503950 ETHLN BLK 6IN 9-0 S/A BV100-4 SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. RABBTB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown