MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ BI VIO 5IN2 0 DA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B409
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
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.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.- when did the needle detach or pull off from the suture thread (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? - please confirm, how many devices demonstrated the alleged deficiency? - were there patient consequences? if yes, please explain.- please provide lot number.- provide the source or name and title of external person providing answers to follow-up h6 component code: g07002 unable to investigate further h3 investigation summary: the product was returned to ethicon for evaluation.One used detached needle and one used needle suture piece outside the winding former was received for analysis.The product code sxpp2b409 was returned for evaluation.Upon visual inspection of the detached needle, the swage and attachment area was noted to be as expected.The barrel hole was examined under magnification, and no suture remnant was noted.The force used to detach the needle from the suture could not be determined.In addition, the needle suture was visually inspected, and the swage and attachment area was noted to be as expected.The suture was examined and the end was noted to be cut likely caused by a surgical instrument.The other section of the suture was not returned for evaluation to determine the assignable cause.The product code sxpp2b409 contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached as to what caused the reported complaint.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent a total knee replacement on (b)(6) 2025 and a barbed suture was used.During the procedure, after the surgeon took the first pass in tissue with 1 of the needles, he noticed the second needle that was attached on a driver had popped off.Another device of the same suture was opened to finish the closure.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: SFXSPI PDS+ BI VIO 5IN2 0 DA CT-1
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21989667
• Report Number: 2210968-2025-05101
• Device Sequence Number: 8313552
• Product Code: NEW
• UDI-Device Identifier: 10705031464674
• UDI-Public: (01)10705031464674(17)260131(10)UBBJQM
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K192144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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: 01/31/2026
• Device Catalogue Number: SXPP2B409
• Device Lot Number: UBBJQM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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