MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	VLOCL0325
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip replacement procedure, the thread broke next to the loop of the device.A new suture was used, but the suture line did not hold.An additional new suture was used without issue.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10.Concomitant products: vlocl0325, vlocl0325 v-loc* 180 2-0 grn 45cm gs21 (lot a3f0486vy); vlocl0325, vlocl0325 v-loc* 180 2-0 grn 45cm gs21 (lot a3f0486vy); vlocl0325, vlocl0325 v-loc* 180 2-0 grn 45cm gs21 (lot a3f0486vy); vlocl0325, vlocl0325 v-loc* 180 2-0 grn 45cm gs21 (lot a3f0486vy).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 knee replacement procedure, the thread broke next to the loop of the device.A new suture was used, but the suture line did not hold.An additional new suture was used without issue.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.A total of six devices were returned; three of them were used by the account and three were sealed representative samples.Visual inspection of the opened samples noted three suture loops broken at the weld site, with the remaining sutures not returned.Medtronic representative samples showed no damage to breathable or foil pouches, properly parked needles, intact retainers, and no abnormalities in the sutures.Functional testing on the opened samples was not possible due to the broken sutures.Representative samples were successfully tested using an instron machine, with no fraying or breakage during handling.All tested sutures met the required specifications, and the laced-through loop test results were satisfactory.It was reported that the thread broke next to the loop of the device.The reported issue was 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.A secondary review of the device history records found no potentially contributing factors.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 180
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22351757
• Report Number: 1219930-2025-02764
• Device Sequence Number: 15709478
• Product Code: GAM
• UDI-Device Identifier: 10884521130999
• UDI-Public: 10884521130999
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K091087
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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: 05/31/2026
• Device Model Number: VLOCL0325
• Device Catalogue Number: VLOCL0325
• Device Lot Number: A3F0486VY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 09/12/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/11/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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