MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 18IN 2-0 SA CT-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B413
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an animal underwent an unknown veterinary procedure on an unknown date and barbed suture was used.During the procedure, complaint: 3 separate sutures were used and all 3 had the same issues.The barbs didn¿t hold in the tissue.They opened an alternative box with a different lot and they didn¿t have the same issue.No adverse patient reactions, the sutures were removed and not left in the patient.Alternative sutures were used to close on the 3 occasions.No adverse patient consequences were 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, 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been made to retrieve the device.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 via: (b)(4) case 1 ¿ no effects recorded for the patient or procedure.Another suture was used.Complaint product is available for return to be evaluated.(b)(4) case 2 ¿ no effects recorded for the patient or procedure.Another suture was used.Complaint product is not available for return to be evaluated.(b)(4) case 3 ¿ no effects recorded for the patient or procedure.Another suture was used.Complaint product is not available for return to be evaluated.I have the box of sutures with a few unopened remaining which are available for return.These are the same batch/lot as the 3 affected cases above.The practice have another box which is a different lot and expiry which are not experiencing any issues with.Contact for external person who reported: (b)(6).I have requested the complaints shipper to be sent and will get these ready as soon as it arrives.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/1/2025 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.H6 component code: g07002 pending evaluation of returned device additional information: d9, h3, h6 a device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/28/2025.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.H6 component code: g07002 no device problem found.Additional information: h3, h6 h3 investigational summary: the product was returned to ethicon for evaluation.One unused strand and four unopened samples were received for analysis.Product code sxmp1b413.During the visual inspection of the returned sample, the sutures were examined along the strands, and no anomalies were observed during evaluation.Ten barbs were measured in the strand, and all barbs met the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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: SFXSPI MCL+ UNI UD 18IN 2-0 SA CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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: 22953274
• Report Number: 2210968-2025-10065
• Device Sequence Number: 15919564
• Product Code: GAM
• UDI-Device Identifier: 10705031236417
• UDI-Public: (01)10705031236417(17)46265(10)103PHU
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: N12159
• 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,Followup
• Report Date (Section B): 09/03/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: SXMP1B413
• Device Lot Number: 103PHU
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 10/08/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/01/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2024
• 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