MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 18IN 2-0 SA FS; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a penal implant procedure on (b)(6) 2024 and barbed suture was used.During a penal implant procedure that the needle broke while suturing.Fragment was recovered.Unknown if x-ray was needed.Another like device was used to continue with the procedure.There were no adverse consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/3/2025.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.The following information was requested, but unavailable: were there any patient consequences? please provide lot number.Were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? asked for update on needle numerous times but not give a response back.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

• Brand Name: SFXSPI PDS+ UNI VIO 18IN 2-0 SA FS
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21067110
• Report Number: 2210968-2025-00081
• Device Sequence Number: 16996514
• Product Code: NEW
• UDI-Device Identifier: 10705031235731
• UDI-Public: 10705031235731
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

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: SXPP1B101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/03/2025
• 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