MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+UNI VIO 6IN 3-0 S/A UR-6; SUTURE, ASBOSRBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B453
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
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.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but unavailable: what is the patient¿s current health status and condition? how was the bleeding treated? please provide details.- was any transfusion necessary? how much blood did the patient lost? confirm the qty in cc.Please refer to the event description, other information requested is unknown.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and barbed suture was used.During the procedure, it was found that the barb on the suture could not hook the tissue, causing the suture to loosen and failing to effectively stop bleeding.A locking clip was used to tighten the loose knot.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.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: h6, 2ab the following additional information was received: received information as following from sales rep via phone today.This event prolonged the surgery time by about 10 minutes and caused tissue bleeding (details unknown).No subsequent adverse event report was received.

• Brand Name: SFX SPI MCRYL+UNI VIO 6IN 3-0 S/A UR-6
• Common Device Name: SUTURE, ASBOSRBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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: 20915488
• Report Number: 2210968-2024-13346
• Device Sequence Number: 12875178
• Product Code: GAM
• UDI-Device Identifier: 10705031470026
• UDI-Public: (01)10705031470026(17)260131(10)UBBJUU
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 01/31/2026
• Device Catalogue Number: SXMP1B453
• Device Lot Number: UBBJUU
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/15/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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 Age: 75 YR
• Patient Sex: Male