MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+UNI VIO 9IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B444
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a lap hysterectomy procedure on (b)(6) 2025 and barbed suture was used.During the procedure, it was reported to the sales rep by the surgeon it was observed during a case after the stratafix was introduced into the abdomen, the loop was broken.The suture was removed and a new one was introduced.The procedure was delayed by three minutes.The procedure was completed successfully with no adverse consequences for the patient.One device returning.No adverse patient consequences were 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.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-conformances were identified.H3 investigation summary: the product was returned to ethicon for evaluation.One used needle-suture was returned for analysis.Product code sxmp1b444.During visual inspection of the sample, marks on the body needle appeared to be by the use of surgical instruments were observed.The suture was examined, and it was observed that the weld of the first loop was detached.It is possible that this failure was due to excessive force being applied.Body fluids and damaged barbs were found on the strand as well.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.The instructions for use do contain the following caution: for the device to function properly, the stratafix¿ spiral pds¿ plus device must first be anchored in robust tissue using the fixation loop.Then subsequently engage the barbs into the tissue in a standard closure pattern.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.- were there any unexpected outcomes or complications resulting from the prolonged surgery time? - which tissue was being sutured when the event occurred? - was additional dissection required in other organs/tissues other than the target tissue? - was there any change in the patient¿s post operative care due to the prolonged procedure? - could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided.- please provide the source or name of person providing answers to follow-up questions:.

• Brand Name: SFX SPI MCRYL+UNI VIO 9IN 2-0 S/A CT-2
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21698749
• Report Number: 2210968-2025-03186
• Device Sequence Number: 8773785
• Product Code: GAM
• UDI-Device Identifier: 10705031470064
• UDI-Public: (01)10705031470064(17)9/30/2026(10)104452
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K221744
• 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): 03/26/2025

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: 09/30/2026
• Device Catalogue Number: SXMP1B444
• Device Lot Number: 104452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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