MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 12IN 0 SA V-34; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B404
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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.- please provide lot number (note: lot number was determined upon device return to manufacturer).A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Investigation summary the product was returned to ethicon for evaluation.It was received, two suture pieces; one of which was attached to the needle.Also, one empty labeled winding former outside its packaging that pertains to product code sxpp1b404.As per the visual inspection of the product received, the swage and attachment area were noted as expected.In addition, the suture suffered thermal deformation, including shrinkage, and melting into the winding former.In the visual inspection of the winding former, no damage or defect on the plastic tray could be observed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the investigation, it was determined that the root cause of the issue pertains to machine ¿ inadequate design as the gifm flow control for the bottom foil sealing does not have the correct algorithm to ensure the cycle completes if the machine is stopped while the die is transitioning from its pre-work state to its sealing completed state.Furthermore, method was identified as a contributing factor as it does not provide instructions to discard the product on the web after an emergency stop, which could potentially lead to a suture melt condition.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 patient underwent an unknown procedure on (b)(6) 2024, and barbed suture was used.When opening the suture it broke and fell apart.Another like device was used to continue with the procedure.There were no adverse consequences reported.Additional information has been requested.

• Brand Name: SFXSPI PDS+ UNI VIO 12IN 0 SA V-34
• 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 PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19518899
• Report Number: 2210968-2024-06118
• Device Sequence Number: 20376122
• Product Code: NEW
• UDI-Device Identifier: 10705031236073
• UDI-Public: 10705031236073
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 11/30/2024
• Device Catalogue Number: SXPP1B404
• Device Lot Number: SPBCAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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