MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	GL-182
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant medical products: gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y gl-182 - gl-182 polysorb* 3-0 vio 75cm cv25 x36, lot# a3m1729y.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a procedure involving the suture, the thread disconnected from the needle while the needle was inside the wound.Additionally, the stitch was described as fragile, and the needle was bent easily.It occurred on 13 sutures.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20844155
• Report Number: 1219930-2024-05633
• Device Sequence Number: 11744831
• Product Code: GAM
• UDI-Device Identifier: 10884521045064
• UDI-Public: 10884521045064
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: GL-182
• Device Catalogue Number: GL-182
• Device Lot Number: A3M1729Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 12/14/2023
• 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