MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 5-0 S/A PS-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J500H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2023 and suture was used.During the procedure, the needle was popping off the suture.The surgeon stated it¿s been happening for months.Another like device was used to complete procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # :(b)(4).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 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.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 via: what is the total number of products involved in this event? n/a.Estimated more than 10.Did the event occur during one or multiple patient procedures? multiple.What is the total number of procedures? n/a, estimated more than 3.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.Please provide the source or name of person providing answers to follow-up questions: (b)(6) via (b)(6) (manager surgery).Mischel also was able to collect some of the affected product for me.I will need to send this in.I have a few boxes of suture collected to have analyzed.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2023-07452, 2210968-2023-07454.
Additional Manufacturer Narrative
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: d9, h3, h6.Investigative summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned devices.The returned samples determined that it was received fourteen unopened samples that pertain to the product code j500h.Upon initial inspection, of the samples, no external damages were observed on the packets.As per the sampling plan, a visual inspection was performed on thirteen samples.The packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.The functional test was performed using instron equipment and the tensile force 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Corrected information: d4 -expiration date; h4 manufacture date.

• Brand Name: VCL CT BRD UD 18IN 5-0 S/A PS-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 17877923
• Report Number: 2210968-2023-07451
• Device Sequence Number: 18006355
• Product Code: GAM
• UDI-Device Identifier: 10705031040687
• UDI-Public: 10705031040687
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: J500H
• Device Lot Number: TJMHUZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 11/03/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/31/2023; 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown