MAUDE Adverse Event Report: ETHICON INC. STFX SPI PDS+ UNI VIO 12IN 2 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B429
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Component code: g07002 - device evaluation pending.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: were the ¿almost nonexistent barbs¿ noted during visual inspection or during use on patient? no.Could you please provide the lot number? qjbclz.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength = 2360 g/m.
Event or Problem Description
It was reported that a patient underwent a robotic hysterectomy on (b)(6) 2021 and a barbed suture was used.During the procedure, the suture had barbs that were almost nonexistent.Another like device from a different lot was used to complete the case.There were no adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/19/2021.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: according to the information received, two sutures had barbs that were 'almost nonexistent.Four packets of product code sxpp1b429 were returned to for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packets.In order to evaluate the conditions of the returned sample, the four packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand to detect any issue related to suture or the loop and no defects were observed during evaluation.Ten barbs were measured in each strand, and all barbs met with the requirements.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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.

• Brand Name: STFX SPI PDS+ UNI VIO 12IN 2 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12009705
• Report Number: 2210968-2021-05601
• Device Sequence Number: 11562549
• Product Code: NEW
• UDI-Device Identifier: 10705031235816
• UDI-Public: 10705031235816
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 07/31/2022
• Device Model Number: SXPP1B429
• Device Catalogue Number: SXPP1B429
• Device Lot Number: QJBCLZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1