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

Model Number	VR916
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).A manufacturing record evaluation was performed for the finished device and no non-conformance's related to the reported complaint condition were identified.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: what was used to complete the procedure? no further information is available.What tissue was being approximated or sutured when it broke? no further information is available.Device return status/follow up: we regularly contact with sales rep about the device returning.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 the suture was broken shortly after starting suturing.There were no adverse patient consequences reported.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 04/01/2020.Additional h3 investigation summary: it was received for analysis an empty labeled winding former and an used needle-suture piece of product code vr916, lot pjcbrqe0.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.However, marks on the body needle and the end of the suture piece cut by the use of a surgical instrument could be observed.Additional, per the condition of the sample the functional test can¿t be performed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.

• 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: 9740203
• Report Number: 2210968-2020-01366
• Device Sequence Number: 2475098
• 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: 01/31/2025
• Device Model Number: VR916
• Device Catalogue Number: VR916
• Device Lot Number: PJCBRQE0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1