MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VR416
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: were there any unexpected outcomes or complications as a result of this suture needle pull off event? there were no adverse consequences to the patient.The following information was requested, but unavailable: was the needle piece removed from the patient during the same procedure? no further information is available.What tissue/location was suturing when pull off occurred? no further information is available.Lot number? no further information is available.
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn surgery on (b)(6) 2021 and suture was used.During the procedure, the suture detached from the needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/25/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional h3 investigation summary: one needle/suture piece of product code vr416 was returned to ethicon inc for analysis.In order to evaluate the conditions of the returned sample, the swage and attachment area were noted to be as expected and a suture piece still was attached to barrel hole needle and the suture end was cut by sharp edge.No needle pull off was observed.As with any device, care should be taken to avoid damage to the strand when handling.Functional test was not performed, due to condition of the sample received.The manufacturing records couldn't be reviewed as the batch number is unknown.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: VICRYL RAPIDE SUTURE 27"(70CM) 3-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12431891
• Report Number: 2210968-2021-08066
• Device Sequence Number: 19681090
• Product Code: GAM
• UDI-Device Identifier: 10705031134645
• UDI-Public: 10705031134645
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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 Model Number: VR416
• Device Catalogue Number: VR416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1