MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ BI VIO 14IN2 2-0 DA CT-1; STRATAFIX SPIRAL PDS PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE

Catalog Number	SXPP2B412
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/28/2024.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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.The returned product determined that it was received two unopened samples that pertain to the product code sxpp2b412.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no issues related to fraying sutures or anomalies were observed during the evaluation.As part of the 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - pending evaluation of returned device.Additional information was requested, the following was obtained: please clarify: was there an issue with the additional product (2- sxpp2b412; lot# tkbjde) for during surgery on this patient? or is this product for another patient event/complaint? if yes, provide the complaint reference.If there were additional sutures sent still in the packaging, this was due to the customer requesting additional sutures be sent over from this lot.A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2024 and barbed suture was used.The suture/needle meeting point the suture looks frayed.They were able to complete the rest of the case with a new one without patient harm.

• Brand Name: SFXSPI PDS+ BI VIO 14IN2 2-0 DA CT-1
• 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: 19614463
• Report Number: 2210968-2024-06628
• Device Sequence Number: 6305738
• Product Code: NEW
• UDI-Device Identifier: 10705031464520
• UDI-Public: 10705031464520
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 08/31/2025
• Device Catalogue Number: SXPP2B412
• Device Lot Number: TKBJDE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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