MAUDE Adverse Event Report: ETHICON INC. ETHICON; SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Catalog Number	497G
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.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)(6) is created for 1st event (mcp942g/ 103930).(b)(6) is created for 2nd event (mcp987h/ uamrce).(b)(6) is created for 3rd event (mcp987h/ 102czu).(b)(6) is created for 4th event (mcp317h/ umbkhd).(b)(6) is created for 5th event (mcp987h/ 103cp2).(b)(6) is created for 6th event (mcp942g/ tlmcht).(b)(6) is created for 7th event (mcp315h/ tgmppt).(b)(6) is created for 8th event (mcp942g/ ubmqqj).(b)(6) is created for 9th event (497g/ spbclq).(b)(6) 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 provide 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 reported: ¿ 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.
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).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.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.
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.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.H6 component code: g07002 no device problem found additional information: d9, h3, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.One open box with two representative unopened samples was received for analysis.Product code 497g.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: ETHICON
• Common Device Name: SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24619376
• Report Number: 2210968-2026-02735
• Device Sequence Number: 18538302
• Product Code: GAQ
• UDI-Device Identifier: 10705031005907
• UDI-Public: (01)10705031005907(17)271130(10)SPBCLQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• 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
• Report Date (Section B): 04/17/2026

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 Catalogue Number: 497G
• Device Lot Number: SPBCLQ
• 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: 04/17/2026; 04/21/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/17/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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