MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	VLOCM2145
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy), vlocm2145, vlocm2145 v-loc* 90 2-0 vio 23cm gs22 (lot#:a2l0345vy) 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
According to the reporter, intra-operatively, while suturing, the thread of 3 sutures broke in the middle.Another suture from another lot was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one suture and one needle.The needle was attached to the suture thread.The suture was measured with a metal yard stick, calibrated asset, and the suture matched the advertised length of nine inches.Upon microscopic inspection, no deformation of the suture barbs was observed and the weld on the loop was intact.It was reported that the suture broke.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: progressive loss of tensile strength and eventual absorption of the absorbable sutures occurs by means of hydrolysis.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.

• Brand Name: V-LOC 90
• 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: 20066485
• Report Number: 1219930-2024-03933
• Device Sequence Number: 12871830
• Product Code: GAM
• UDI-Device Identifier: 10884521133013
• UDI-Public: 10884521133013
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 10/31/2025
• Device Model Number: VLOCM2145
• Device Catalogue Number: VLOCM2145
• Device Lot Number: A2L0345VY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown