MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 9IN 2-0 SA CT-2; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B432
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
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.Please confirm the procedure date: (b)(6) 2024.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned 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 have been made to retrieve the device.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.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.* if possible, please confirm the lot number of the suture that broke.Spbdur or tmbepa? * what is the procedure name and date? * please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) * please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2024 and barbed suture was used.During the procedure, the stratafix suture broke.They opened another suture to complete the case.No patient harm.The used product is not available for return but will be sending back sterile packs.There were no adverse consequences reported.Additional information was requested.
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.Additional information was requested, and the following was obtained: * if possible, please confirm the lot number of the suture that broke.Spbdur or tmbepa? or couldn't find the package * what is the procedure name and date? lap hystrectomy, 3rd week of august * please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) na * please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.They don¿t have the defect suture 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 confirm the procedure date (currently reported as 3rd week of august).The alert date for this file is reported as 19 jul 2024.

• Brand Name: SFXSPI PDS+ UNI VIO 9IN 2-0 SA CT-2
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19991960
• Report Number: 2210968-2024-08558
• Device Sequence Number: 15218172
• Product Code: NEW
• UDI-Device Identifier: 10705031246539
• UDI-Public: (01)10705031246539(17)241130(10)SPBDUR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2024

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: 11/30/2024
• Device Catalogue Number: SXPP1B432
• Device Lot Number: SPBDUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 09/27/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/11/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2022
• 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