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

Catalog Number	VCP427H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.
Event or Problem Description
It was reported that a patient underwent a hardware removal tendon transfer procedure on (b)(6) 2019 and suture was used.The needle detached during suturing.The procedure was completed with this same suture material using much slower pass through and pulling of suture.It took longer to close incision due to extra precaution used to keep needle from detaching.No adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• 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: 8464187
• Report Number: 2210968-2019-79801
• Device Sequence Number: 1341683
• Product Code: GAM
• UDI-Device Identifier: 10705031053151
• UDI-Public: 10705031053151
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 07/31/2023
• Device Catalogue Number: VCP427H
• Device Lot Number: MJ7659
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1