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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished lot device and no non-conformances were identified.Additional evaluation summary: representative samples were returned for evaluation.During the visual inspection, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed using and the pull force were above the minimum requirements.Per the conditions of the samples received, no performance pull off suture needle were found, and the tested sample met the finished goods requirements.Additional information was requested and the following was obtained: event date? on (b)(6) 2019.Procedure name: hardware removal tendon transfer.Quantity involved? 1.When did the issue occur? needle detached during suturing.How was case completed? completed with this same suture material using much slower pass through and pulling of suture.Any adverse patient consequences? no.Took longer to close incision due to extra precaution used to keep needle from detaching.
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.

• 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: 8462881
• Report Number: 2210968-2019-79791
• Device Sequence Number: 16479033
• 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
• Report Date (Section B): 03/08/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/28/2019
• Patient Sequence Number: 1