MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 24IN 3-0 SA PS-1 PMP; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B103
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
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.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested, and the following was obtained via: contact: (b)(6).The information i have is that the loop was open when the sutures arrived.Please provide additional details of the reported alleged deficiency (¿the loop went up¿).Please confirm, how many devices are available to be returned for product analysis.Provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).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.Did the alleged deficiency noted with the device prior usage on the patient or during the procedure? please clarify.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and barbed suture was used.During the procedure, the loop went up, they opened a new suture and the same thing happened again.3 sutures where the same thing happened.There were no adverse 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, 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.Corrected information: d3.Additional information: d9, h3, h6.Additional h6 component code: g07002 no device problem.Additional h6 investigation findings: c22 - photo review.Additional h3 investigation summary: the product was returned to ethicon for evaluation.Two unopened samples were that pertain to product code sxmp1b103 were received for analysis.To evaluate the condition of the returned samples, the packets were opened.The swage and attachment area was noted as expected.The sutures were examined, and no anomalies or defects were observed.In addition, the loops were noted to be as expected.Furthermore, two photos were provided.The first image showed one open box.In the second photo, a used needle-suture combination was noted, with the weld of the first loop detached due to excessive force applied, and body fluids were observed.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although 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.Additional information was requested, and the following was obtained: they will return the rest of the sutures in the box, i don´t have information about the exaxt amount.

• Brand Name: SFXSPI MCL+ UNI UD 24IN 3-0 SA PS-1 PMP
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21654322
• Report Number: 2210968-2025-02990
• Device Sequence Number: 7527270
• Product Code: GAM
• UDI-Device Identifier: 10705031236622
• UDI-Public: (01)10705031236622(17)7/31/2026(10)102TM0
• Combination Product (Y/N): Y
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 04/17/2025

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: 07/31/2026
• Device Catalogue Number: SXMP1B103
• Device Lot Number: 102TM0
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2024
• 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