MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 12IN 3-0 SA PS-2 PR; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.H3 investigation summary: the product was returned to ethicon for evaluation.One dispensed needle suture combination and one empty labeled winding former were received for analysis.Product code sxpp1b104.During the visual inspection of the sample, marks likely caused by a surgical instrument were noted on the needle.The suture was examined, and the weld of the first loop was found to be detached.However, this mode of failure was probably caused by excessive force applied.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as on what caused the reported complaint.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: lot number of ip-02368718: unk: 1012ab.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.Lot # 1012ab was provided in note a-13062215, however lot # 1011ga was obtained from the returned device.What is the correct lot number for this complaint?.
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic surgery on (b)(6) 2025 and a barbed suture was used on the dermis.During the procedure, the loop part was broken although no extra tension was applied.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/13/2025 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.Additional information was requested, the following was obtained: lot # 1012ab was provided in note a-13062215, however lot # 1011ga was obtained from the returned device.What is the correct lot number for this complaint? unk additional information: d4 (lot) - the actual product code associated with this event is not known.The possible product codes are reported as follows product code 1012ab product code 1011ga.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/10/2025.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.Additional information: h6.Additional information: d4, h4 - the actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch 1011ga udi: (b)(4).Batch 1012ab udi: (b)(4).A manufacturing record evaluation was performed for the finished device batch 1011ga and no non-conformances were identified.Mfg.Date - 05/13/2024.Exp.Date - 04/30/2026.A manufacturing record evaluation was performed for the finished device batch 1012ab, and no non-conformances related to the reported complaint condition were identified.Exp.Date: 04/30/2026.Mfg.Date: 05/14/2024.

• Brand Name: SFXSPI PDS+ UNI VIO 12IN 3-0 SA PS-2 PR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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: 22029755
• Report Number: 2210968-2025-05411
• Device Sequence Number: 15489295
• Product Code: NEW
• UDI-Device Identifier: 10705031236240
• UDI-Public: (01)10705031236240(17)260430(10)1011GA
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K182873
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2025

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: 04/30/2026
• Device Catalogue Number: SXPP1B104
• Device Lot Number: 1011GA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 06/13/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/13/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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