MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	VLOCN0327
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of four devices.However, analysis suggests that the product was not used in a surgical procedure.The visual inspection and functional evaluation of the product had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: the strand of the suture broke at the loop which holds the suture in place.Occurred when anchoring the suture down.Four sutures with the same lot number were opened with two breaking.In order to resolve the issue and complete the case, used another suture of the same type.There were no patient symptoms or complications associated with this event.Current patient status is with no injury.
Additional Manufacturer Narrative
Initial notification of this reportable event to fda.If information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7316173
• Report Number: 1219930-2018-01236
• Device Sequence Number: 13482522
• Product Code: GAT
• UDI-Device Identifier: 10884521127906
• UDI-Public: 10884521127906
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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: 03/31/2019
• Device Model Number: VLOCN0327
• Device Catalogue Number: VLOCN0327
• Device Lot Number: A6C0615VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1