MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ BI VIO 5IN2 4-0 D/A PS-2 PR; STRATAFIX SPIRAL PDS PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE

Catalog Number	SXPP2B423
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a bt: blalock-taussig shunt procedure on (b)(6) 2023 and suture was used.During a bt: blalock-taussig shunt, after two stitches in the dermis, the needle was detached from the suture.Another product was used.It was not a control release needle.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/26/2023.H6 component code: g07002 - device not returned.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.The following additional information was received: there were no adverse consequences to the patient.The following additional information was requested, but unavailable: please provide the lot number: unk.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.We regularly contact with sales rep about the device returning.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.Trade name - irgacare active ingredient(s)- triclosan dosage form - suture/solid/parenteral strength - = 2360 g /m.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Date sent to the fda: 5/24/2023.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample revealed that it was received one empty labeled winding former, one needle-suture piece, and one detached needle that pertain to the product code sxpp2b423.The product code is double-armed.Upon visual inspection, the returned sample was evaluated.The swage and attachment area were noted to be as expected.On the detached needle, marks on the body and the edge needle that appears to be by a surgical instrument could be observed.The needle-suture piece was noted cut and marks near of the end possibly caused by a surgical instrument.As part of ethicon 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: SFX SPI PDS+ BI VIO 5IN2 4-0 D/A 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16815660
• Report Number: 2210968-2023-03002
• Device Sequence Number: 14873554
• Product Code: NEW
• UDI-Device Identifier: 10705031464599
• UDI-Public: 10705031464599
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: SXPP2B423
• 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: 04/07/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (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