MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 27IN 3-0 S/A PS PRM; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B109
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.When did the issue occurred (removal from package /during passage through tissue/ during tying / post-op)? what is the lot number? product investigation: 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 open sample that pertain to product code sxpp1b109.During visual inspection of the returned sample, marks probably caused by a surgical instrument could be observed.The suture was cut in two sections and body fluids were found along of strand.In addition, the loop area was not returned for analysis.The manufacturing records could not be reviewed as the batch/lot number is unknown.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what caused the reported complaint.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and barbed suture was used.The surgeon had the loop end of the suture break off, making it unusable.There were no patient consequencess.Additional information was requested.

• Brand Name: SFX SPI PDS+ UNI VIO 27IN 3-0 S/A PS PRM
• Common Device Name: 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17126666
• Report Number: 2210968-2023-04302
• Device Sequence Number: 6487594
• Product Code: NEW
• UDI-Device Identifier: 10705031236264
• UDI-Public: 10705031236264
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K150670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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 Model Number: SXPP1B109
• Device Catalogue Number: SXPP1B109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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