MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 36"(90CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VR916
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: was the patient¿s post-operative course changed as a result of the extended procedure? if yes, please explain.No further information is available.Product return status: the device will be shipped.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn surgery on (b)(6) 2020 and the suture was used.It was also reported that when opening the package, it was found that the suture had been detached from the needle.It was not a control release needle.There were no adverse patient consequences reported.No further information is available.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot pcccdqe0, and no non-conformances were identified.Additional h3 investigation summary: a detached needle, a dispensed suture and an empty opened foil of product code vr916, lot # pcccdqe0 were returned for analysis.During the visual inspection of detached needle, the swage and attachment area was noted to be as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the opened sample, the assignable cause is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.

• Brand Name: VICRYL RAPIDE SUTURE 36"(90CM) 3-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9740766
• Report Number: 2210968-2020-01367
• Device Sequence Number: 2475099
• Product Code: GAM
• UDI-Device Identifier: 10705031134751
• UDI-Public: 10705031134751
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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 Expiration Date: 08/31/2024
• Device Model Number: VR916
• Device Catalogue Number: VR916
• Device Lot Number: PCCCDQE0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/30/2020
• Patient Sequence Number: 1