MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 3-0 S/A SH MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y316H
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2022 and suture was used.During the procedure, the surgeon reported the monocryl suture that he has been using for over a decade has changed in quality the last 6 months.The suture poor handling characteristics resembles a prolene.The suture he is used to has a stretchy like feel, minimal memory and ties securely.Recently, the monocryl suture is unraveling, and knots are not securely tying down loosening once complete.He is having to throw extra knots.No adverse patient consequences were reported.Additional information was requested.
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 was requested, and the following was obtained: it was reported the doctor has tried several suture from various lots and different procedures all have the same unsatisfactory result.Please confirm what is the total number of procedures? states last 6 mo at least.Potentially 12-15.What is the total number of products involved during the robotic inguinal hernia case? 1.What is the total number of products involved in each case? 1-2.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).(b)(4).Please provide the source or name of person providing answers to follow-up questions: (b)(6).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 device analysis: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned samples determined that it was received one unopened sample, that pertain to product code y316h.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area was noted to be as expected.The suture was dispensed without problems and examined along the strand.In addition, no issues related to the untying knot or anomalies on the strand were observed during the evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.

• Brand Name: MCRYL VIO 27IN 3-0 S/A SH MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17695736
• Report Number: 2210968-2023-06455
• Device Sequence Number: 19494489
• Product Code: GAN
• UDI-Device Identifier: 10705031058743
• UDI-Public: 10705031058743
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• 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
• Report Date (Section B): 09/06/2023

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: Y316H
• Device Lot Number: SBMQBL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2022
• 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