MAUDE Adverse Event Report: LSI SOLUTIONS, INC. TK® TI-KNOT®; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	030404
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The ti-knots were found to be not sitting correctly on the device.This device was removed from the surgical area and another device was used.

• Brand Name: TK® TI-KNOT®
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): LSI SOLUTIONS, INC.; 7796 victor-mendon rd; victor NY 14564
• MDR Report Key: 20211650
• Report Number: 20211650
• Device Sequence Number: 15316105
• Product Code: GAW
• UDI-Device Identifier: 00850200006094
• UDI-Public: (01)00850200006094(17)261130(10)2254786
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024
• Report Date (Section F): 06/13/2024

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 Model Number: 030404
• Device Catalogue Number: 030404
• Device Lot Number: 2254786
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Date Report Sent to FDA: 06/13/2024