MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y426H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in (b)(6) 2025 and suture was used.During the procedure, it was reported to the rep that over the past month during multiple procedures that the suture is breaking in random spots.Another like device would be used to continue with the procedure.No samples returning.There were no adverse 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.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.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.Sxpp2b405.(b)(4) represents the initial reporting of the events.(b)(4) represents the ambiguous number of events.When were the sxpp2b405 sutures 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 procedures involved? have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? please provide the source or name of person providing answers to follow-up questions: y426h.(b)(4) represents the initial reporting of the events.(b)(4) represents the ambiguous number of events.When were the y426h sutures 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 procedures involved? have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? please provide the source or name of person providing answers to follow-up questions:.
Additional Manufacturer Narrative
(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: h6, h4.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.The following information was received: new event reported not included in previous file or ambiguous file, (b)(4).

• Brand Name: MCRYL UD 27IN 4-0 S/A PS-2 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: 21678854
• Report Number: 2210968-2025-03099
• Device Sequence Number: 18042299
• Product Code: GAN
• UDI-Device Identifier: 10705031059146
• UDI-Public: (01)10705031059146(17)8/31/2029(10)103LKH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• 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
• Report Date (Section B): 05/02/2025

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: Y426H
• Device Lot Number: 103LKH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/05/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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