MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 6IN 3-0 SA RB-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B422
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/23/2024.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but unavailable: what was the name of the procedure? unk.What was the procedure date? unk.When was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify: unk.What was used to complete the procedure? another device was used.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at (b)(6) and will be shipped.Please check rmao.Tracking number: (b)(4).Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq): (b)(6).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 barbed suture was used.During an unknown surgery, the suture was detached from the needle.It was not a control release needle.There were no adverse consequences to the patient.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.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.H3 investigation summary: the product was returned to ethicon for evaluation.One needle and one suture outside their packaging.Product code sxpp1b422.After investigation of the sample, the swage and attachment area were not as expected; since the hit of the stake was on the edge of the swage area of the needle, causing a clip-off on the suture due to an incorrect swage.Based on the information currently available, an incorrect swage issue was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: SFXSPI PDS+ UNI VIO 6IN 3-0 SA RB-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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20055971
• Report Number: 2210968-2024-08873
• Device Sequence Number: 20827611
• Product Code: NEW
• UDI-Device Identifier: 10705031235939
• UDI-Public: (01)10705031235939(17)240930(10)SLBDUQ
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 09/30/2024
• Device Catalogue Number: SXPP1B422
• Device Lot Number: SLBDUQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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