MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A CS160-6; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	U7000
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: 3/24/2026.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: ¿(b)(4) captures the initial report for "during cataract surgery performed by hcp, the suture was detached from the needle (swage end)." ¿ (b)(4) captures the ambiguous multiple event report.- how many devices demonstrated the alleged deficiency? - did the event occur during one or multiple patient procedures? - what is the total number of procedures? - have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? - if this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? - please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).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 a cataract procedure on an unknown date and suture was used.It was reported by or sister that during cataract surgery performed by hcp, the suture was detached from the needle (swage end).According to feedback received, this incident has occurred a few times previously but was not formally reported by the or nurses.No patient consequence 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: h6 additional information was requested, and the following was obtained via: 1.How many devices demonstrated the alleged deficiency? ans: 4 pieces 2.Did the event occur during one or multiple patient procedures? ans: multiple but sister janet not sure the exact number.3.What is the total number of procedures? ans: sister janet unable to recall, this is because the staff nurse did not update her at the time when the sutures issues was encountered.4.Have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? ans: no.Only recent (b)(4) & (b)(4) being reported.5.If this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? ans: already created (b)(4) 6.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).Ans: (b)(6) (nurse- ot manager)".

• Brand Name: ETHLN BLK 12IN 10-0 D/A CS160-6
• Common Device Name: SUTURE, NONABSORBABLE, 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24694336
• Report Number: 2210968-2026-03066
• Device Sequence Number: 10463097
• Product Code: GAR
• UDI-Device Identifier: 10705031000094
• UDI-Public: (01)10705031000094(17)300831(10)10ARJG
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: U7000
• Device Lot Number: 10ARJG
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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