MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI 18IN 4-0 SA PS-4 PRM; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B119

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

It was reported a patient underwent an unknown surgery on (b)(6) 2022 and barbed suture was used.The loop was smaller than usual during use.Thus, the surgeon stopped using the product.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Please confirm if the loop or tab broke during use, nothing was broken.The issue was the loop was smaller than usual.Please provide the lot number: skbeep.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.No further information will be provided." this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name: irgacare® active ingredient(s).Triclosan dosage form: suture/solid/parenteral strength 2360 g/m.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.

Manufacturer Narrative

Product complaint # (b)(4) date sent to the fda: 2/2/2023 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.Additional information: d4, d9, h3, h4, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that it was returned one suture that pertain to product code sxpp1b119.During the visual assessment of the suture, the first loop was noted to be as expected.However, the second loop could be observed as closed until the end.In addition, the needle was cut probably caused by a surgical instrument.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.Although no conclusion could be reached on the cause of the reported event.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 will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: SFX SPI PDS+ UNI 18IN 4-0 SA PS-4 PRM
• Type of Device: 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16114836
• MDR Text Key: 307733049
• Report Number: 2210968-2023-00135
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031240889
• UDI-Public: 10705031240889
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K150670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: SXPP1B119
• Device Catalogue Number: SXPP1B119
• Device Lot Number: SKBEEP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1