MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 18"(45CM) 5-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR490
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported performance pull off suture needle.A paper lid, an empty winding former and a suture piece of product code vr490 were returned for analysis.During visual inspection of the sample, the insertion mark could not be observed and the other extreme was cut that appears to be by use of surgical instrument.In addition, the needle was not returned for evaluation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the sample, it could not be determined what may have caused the reported incident of: ¿ the needle popped off of the suture at the swage¿.
Event or Problem Description
It was reported that an animal underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the needle popped off of the suture at the swage.A second like device was used to complete the procedure with no consequences reported.No additional information was provided.

• Brand Name: VICRYL RAPIDE SUTURE 18"(45CM) 5-0 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: 8645385
• Report Number: 2210968-2019-82034
• Device Sequence Number: 1925013
• Product Code: GAM
• UDI-Device Identifier: 10705031134591
• UDI-Public: 10705031134591
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 10/31/2023
• Device Catalogue Number: VR490
• Device Lot Number: AL3938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/28/2019
• Patient Sequence Number: 1