MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP215H
Medical Device Problem Codes	Material Frayed (1262); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: an unopened sample of product code vcp215, lot pbz938 was returned for analysis.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problem and examined along of the strand and no defects, fraying suture or diameter issue were noted.A functional test was performed to strands using a federal gauge to measure the suture diameter and the result meet the requirements.Per the condition of the representative sample, no performance fraying suture intra-op or suture diameter was found and the tested sample met the finished goods requirements.A manufacturing record evaluation was performed for the finished device lot number pbz938 and no non-conformances were identified.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on unknown date in 2019 and suture was used.The suture was fraying during use, and almost popping off from the needle.The suture felt thinner than normal and weak composition.The suture felt as if it was going to rip when securing to tie the knot.There were no adverse patient consequences reported.

• Brand Name: VICRYL PLUS SUTURE 27"(70CM) 3-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8689022
• Report Number: 2210968-2019-82631
• Device Sequence Number: 16731591
• Product Code: GAM
• UDI-Device Identifier: 10705031051683
• UDI-Public: 10705031051683
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 01/31/2024
• Device Catalogue Number: VCP215H
• Device Lot Number: PBZ938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/11/2019
• Patient Sequence Number: 1