MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 4-0 S/A SH MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y315H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a laparoscopic hernia procedure on (b)(6) 2024 and suture was used.During the procedure, the suture broke many times.The product was discarded due to the patient having an infection.There were no adverse consequences to the patient.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned.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: it was reported that ".The products were discarded due to infection." was infection observed in the patient? please provide additional details.Since the device was used for the patient had an infection, it was discarded and could not be received for analysis.Please provide lot number: unk.It was reported that ".The sutures were broken many times.".Please clarify how many devices were used on this single event.Unk.If there are multiple patient events: this event occurred in one procedure.What is the total number of events? na.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts were made to obtain the information.If further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: MCRYL VIO 27IN 4-0 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20085024
• Report Number: 2210968-2024-09032
• Device Sequence Number: 12676317
• Product Code: GAN
• UDI-Device Identifier: 10705031058729
• UDI-Public: 10705031058729
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2024

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: Y315H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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