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

Model Number	VLOCM1413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the sample noted two sutures and two needles.Upon microscopic inspection of the needles, normal needle crimp and swage marks were observed on the needles.A tactile and microscopic inspection of the sutures was performed with no abnormalities.Upon microscopic inspection of the loops, the loops appear to have broken under tension.The loops showed evidence of material transfer indicative of proper welding.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: occurred during a thyroidectomy.The loop broke.To complete the procedure, another suture was opened but that loop was broken discovered to be broken in the package.No patient injury or extension in surgical time.Patient status is no problem.
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 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7316641
• Report Number: 1219930-2018-01256
• Device Sequence Number: 19275772
• Product Code: GAM
• UDI-Device Identifier: 20884521132785
• UDI-Public: 20884521132785
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• 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: 10/31/2019
• Device Model Number: VLOCM1413
• Device Catalogue Number: VLOCM1413
• Device Lot Number: A6K0151VFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 03/22/2017
• 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