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	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a thyroidectomy procedure (b)(6) 2023 and suture was used.Before use on the patient, it was reported that the problem of pulling off suture needle had happened in the newly dispensed suture when it was opened to prepare for surgery.Changed another one to complete the surgery.The product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received one needle and suture that pertain 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, short insertion issue was identified as pull out during the investigation of the sample received.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (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.H3 investigation summary:the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received one needle and suture that pertain 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, 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.

• 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: 18035595
• Report Number: 2210968-2023-08353
• Device Sequence Number: 8398189
• Product Code: NEW
• UDI-Device Identifier: 10705031244962
• UDI-Public: 10705031244962
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2023

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 Catalogue Number: SXPP1A441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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