MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 54"(135CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	D6819
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that the patient underwent total knee replacement on (b)(6) 2019 and suture was used.The needle prematurely popped off while suturing.This occurred after several passes.The case was completed with another device of the same product code.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: an empty opened folder and a detached needle of product code d6819, were received for evaluation.During the visual inspection of detached needle, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted and marks that appears to be by use of a surgical instrument could be observed on the body needle.The suture was not received for evaluation to determine the assignable cause.The manufacturing records couldn't be reviewed as the batch number is unknown.It could not be determined what may have caused the reported incident.

• Brand Name: VICRYL SUTURE 54"(135CM) 1 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: 8579491
• Report Number: 2210968-2019-81031
• Device Sequence Number: 13849699
• Product Code: GAM
• UDI-Device Identifier: 10705031026834
• UDI-Public: 10705031026834
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: Health Professional
• Device Catalogue Number: D6819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/29/2019
• Patient Sequence Number: 1