MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 24IN 0 S/A CT; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A441
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a abdominoplasty on (b)(6) 2023 and barbed suture was used.During the procedure, when opening the thread, it was outside the needle.The suture broke completely on the first pass and came loose from the needle.It was intact on the first pass and broke.When pulled, it came off the needle.The thread came off the needle and they think it came with a factory defect.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 10/23/2023.H6 component code: g07002.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.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: device follow up did the suture break or did it come loose from the needle? or did both suture breakage and suture pull off needle occur? was there any patient consequence? to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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.Additional information was requested and the following was obtained: the event description states the suture broke completely and came loose from the needle.Did the suture break or did it come loose from the needle? a: it was out from the needle.Or did both suture breakage and suture pull off needle occur? a: the suture was pulled off from the needle.Was there any patient consequence? a: no, there was no consequence to the paciente since they did not use the suture/needle when they saw the suture was out from the needle.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/18/2024.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.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 revealed that it was received one opened sample that pertained to product code sxpp1a441.After investigation of the sample, short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.Based on the information currently available, the short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: STFX SYM PDS+ UNI VIO 24IN 0 S/A CT
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17987363
• Report Number: 2210968-2023-08110
• Device Sequence Number: 18192449
• Product Code: NEW
• UDI-Device Identifier: 10705031244962
• UDI-Public: 10705031244962
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2024

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: 02/28/2025
• Device Catalogue Number: SXPP1A441
• Device Lot Number: TCMDMH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 10/20/2023; 03/05/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/15/2023; 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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