MAUDE Adverse Event Report: COVIDIEN SURGICAL V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	VLOCM0024
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open bone tumor surgery, at the skin suturing step, three absorbable sutures were found to be defective in succession.The first pack exhibited a cracked tail loop after the first stitch, the second pack had the needle and thread detach, and the third pack experienced thread breakage.All issues occurred within less than five minutes of use and during intradermal continuous suturing.The defective sutures were replaced with regular absorbable thread from another manufacturer to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10 concomitant product: vlocm0024, vlocm0024 v-loc* 90 3-0 clr 45cm p12x12 (lot#a4k2044vfy); vlocm0024, vlocm0024 v-loc* 90 3-0 clr 45cm p12x12 (lot#a4k2044vfy).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.The device was available for evaluation.The visual inspection of the returned product noted one suture and one needle.The needle was returned disengaged from the suture.Upon microscopic inspection, instrument marks were noted near the swaged end of the needle.Suture material was observed to be present in the swage, indicating the suture broke off at the swage.Functional testing on the opened complaint device was precluded as the needle was returned detached.It was reported that the needle and thread detached.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the needle was grasped near the swaged end or the tip and could cause bends, breaks, or damage the connection between the needle and suture.The evaluation detected an unreported condition: suture broken.Visual examination noted that the suture was observed to be broken at the barbed section and the loop end was missing.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.The instructions included with this device provide the following guidance: during employment of the device, care should be taken to avoid damage to the surgical needles from handling.Grasp the needle in an area one-third to one half of the distance from the attachment end to the needle point.Grasping near the point could result in damage to the functional integrity or fracture the needle.Grasping at the attachment area could cause breakage of the needle barrel or the absorbable thread in the attachment area.Reshaping needles may result in decreased resistance to bending and breaking.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 SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23633444
• Report Number: 1219930-2025-05439
• Device Sequence Number: 21177442
• Product Code: GAM
• UDI-Device Identifier: 10884521131699
• UDI-Public: (01)10884521131699(17)270930(10)A4K2044VFY(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: VLOCM0024
• Device Catalogue Number: VLOCM0024
• Device Lot Number: A4K2044VFY
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Patient Sex: Unknown