MAUDE Adverse Event Report: ETHICON INC. MONOCRYL PLUS UD 27IN USP3-0; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number MCP458H

Device Problems Break (1069); Defective Component (2292); Dull, Blunt (2407); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The thread sticks and after 2 passes through the skin, the needle no longer pricks.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint (b)(4).H6.Component code: g07002.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: was there any adverse consequence associated with the patient? no consequences for the patient.New threads were opened each time.Could you please provide more details about how the wires hang? do you have any photos available for visual analysis? no photos available, it is difficult to remove the thread from the packaging, can cause thread-needle disunity.In addition, the surgeon also found a reduction in the quality of the needle in terms of penetration.What is the current status of the patient? the patients are doing very well.The real problem is that this causes the use of more threads because they break, this deeply annoys practitioners and they lose confidence in the quality of the thread.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that "the real problem is that this causes the use of more threads because they break", please clarify: when was the threads broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.What is the total number of broken sutures involved in each case? did the event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/11/2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.H3 investigational 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, ten packets that pertain to product code mcp458h.Upon visual inspection of the returned sample, the sutures were dispensed without problems from winding former and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.The returned needles were noted to be the corresponding reverse cutting prime needle for the mcp458h product code.No damages or needle deformation were observed during the visual inspection.The needles were passed through a tissue simulator and no abnormalities were noted.The functional test was performed using an instron equipment and the tensile strength force was above the minimum requirement.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Product complaint # (b)(4).Date sent to the fda: 12/11/2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 11/15/2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Additional information was requested, the following was obtained: were there any patient consequences? no, but surgeon's irritation.Please provide the procedure name and date? date: (b)(6) 2023.Procedure name: abdominal dermolipectomy (adl).

• Brand Name: MONOCRYL PLUS UD 27IN USP3-0
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17961999
• MDR Text Key: 326846784
• Report Number: 2210968-2023-07978
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K050845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCP458H
• Device Lot Number: TEMLBL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/23/2023; 11/16/2023
• Supplement Dates FDA Received: 11/15/2023; 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1