MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 27"(70CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP333H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.It was reported that suture breakage occurred during suture process.Changed another one to complete surgery.There was no adverse patient outcome reported.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: an empty opened foil, a labeled winding former and a needle-suture in several pieces of product code vcp333, lot le7087 were returned for analysis.During the visual inspection of the sample, body fluids were observed along of strands and the end of suture pieces were busted due to the suture has begun with the degradation process and no functional test could be performed.The foil was examined and showed multiples wrinkles and holes in cavity on bottom foil package due to excessive manipulation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, the assignable cause of performance breakage suture, is suture degradation; due to the improper handling of package.

• Brand Name: VICRYL PLUS SUTURE 27"(70CM) 2-0 VIO
• 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: 8484745
• Report Number: 2210968-2019-80029
• Device Sequence Number: 16624885
• Product Code: GAM
• UDI-Device Identifier: 10705031052390
• UDI-Public: 10705031052390
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: No Information
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: VCP333H
• Device Lot Number: LE7087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1