MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ BI VIO 5IN2 3-0 DA PS-2 PR; STRATAFIX SPIRAL PDS PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE

Catalog Number	SXPP2B100
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2024 and barbed suture was used.During the procedure, during continuous suturing, the spiral barb is weak.Especially, the half of the barb seems to have a weak impression.It was not a control release needle.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).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.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.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 9/18/2024.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.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.One used needle suture in two sections and one empty foil were received for analysis.During the visual inspection of the returned sample, marks that appear to be caused by a surgical instrument were observed on the body needles.The suture pieces were examined, and body fluids were noted along strands.As per the condition of the sample, the barbs could not be measured.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.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.

• Brand Name: SFXSPI PDS+ BI VIO 5IN2 3-0 DA PS-2 PR
• Common Device Name: STRATAFIX SPIRAL PDS PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE
• 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: 20129235
• Report Number: 2210968-2024-09243
• Device Sequence Number: 3266028
• Product Code: NEW
• UDI-Device Identifier: 10705031465190
• UDI-Public: (01)10705031465190(11)230508(17)250430(10)TEBBPK
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 04/30/2025
• Device Catalogue Number: SXPP2B100
• Device Lot Number: TEBBPK
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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