MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP317H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 3/17/2026.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.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: ten product complaints were created to document 10 different cases (b)(4) is created for 1st event (mcp942g/ 103930), (b)(4) is created for 2nd event (mcp987h/ uamrce), (b)(4) is created for 3rd event (mcp987h/ 102czu), (b)(4) is created for 4th event (mcp317h/ umbkhd), (b)(4) is created for 5th event (mcp987h/ 103cp2), (b)(4) is created for 6th event (mcp942g/ tlmcht), (b)(4) is created for 7th event (mcp315h/ tgmppt), (b)(4) is created for 8th event (mcp942g/ ubmqqj), (b)(4) is created for 9th event (497g/ spbclq), (b)(4) is created for 10th event (z969h/ 109ls).Please provide the following information for each case: it was reported that "last 3 time the needle comes apart from the suture".Did all the reported devices have this issue? if no, please porvide additional details.When did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? if different, please explain.Is this device or samples from same lot available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number) credit was requested.Please provide a copy of the ethicon invoice to complete this request.The following information was received: we have not removed this issue to ethicon before now all 10 products referenced are associated with separate events.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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported by the distributor that needles are defected.Last 3 time the needle comes apart from the suture.No adverse impact was reported.Device is available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/4/2026 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: d4, h4 corrected information: g1 additional information was requested, the following was obtained: this product was returned, so i do not have it to confirm the lot number.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 type of investigation: b21 - device evaluation pending.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, 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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information: h6, d9.

• Brand Name: MCRYL+ VIO 27IN 2-0 S/A SH
• 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 PR 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24619577
• Report Number: 2210968-2026-02740
• Device Sequence Number: 21226459
• Product Code: GAM
• UDI-Device Identifier: 10705031046375
• UDI-Public: (01)10705031046375(17)260131(10)UMBKHD
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2026

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 Expiration Date: 01/31/2026
• Device Catalogue Number: MCP317H
• Device Lot Number: UBMKHD
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 05/07/2026; 05/23/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/04/2026; 05/14/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2024
• 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