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

Catalog Number	SXPP1B405
Medical Device Problem Code	Material Separation (1562)
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).Date sent to the fda: 6/24/2025.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.Corrected information: h6 (b18 - device discarded).
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/18/2025.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.Additional information was requested; the following was obtained: - how long was the delay? please specify in minutes.¿ unknown.Time was required to find the needle that had fallen into the patient's abdominal cavity.- were there any unexpected outcomes or complications as a result of the prolonged surgery time? ¿ unknown.No consequences reported.- did the needle fall into the patient? if so: yes *was the needle removed from the patient during the same procedure? ¿ yes, needle was immediately removed once found.What measures were taken to retrieve the needle? ¿ the needle was found visually.- please provide lot number.¿ the suture and packaging were discarded by the staff.No lot numbers are available to report.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).¿ dr.(b)(6) reported the incident to me verbally.The following information was reported: was surgery delayed due to the reported event? yes, if yes, number of minutes: unknown, action taken when event occurred? time taken to find needle.Needle found.No x-ray needed.Was procedure successfully completed? yes, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported by the surgeon that the needle popped off of the suture when attempting to remove from the trocar.8mm airseal brand trocar used with a ct-2 needle.The procedure was completed successfully with no adverse consequences for the patient.Additional information was requested.

• Brand Name: SFXSPI PDS+ UNI VIO 12IN 0 SA CT-2
• 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: 22284459
• Report Number: 2210968-2025-07049
• Device Sequence Number: 12839590
• Product Code: NEW
• UDI-Device Identifier: 10705031236080
• UDI-Public: 10705031236080
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K150670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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 Catalogue Number: SXPP1B405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/22/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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