MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 36"(90CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J474H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lpz717 number, and no non-conformance's were identified.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.When we send the sample to you, we will let you know its return date and tracking number.Please confirm the specific number of devices (total qty actually involved with reported issue) that failed during this one event report/procedure ? it is reported 3 needle-sutures.Or was the reported event of "occurred in 3 needle-sutures in the same lot" noticed with multiple procedures? ne procedure.Events reported via mw 2210968-2019-82815, 2210968-2019-82816, 2210968-2019-82817.
Event or Problem Description
It was reported that the patient underwent an unknown obgyn procedure on an unknown date and suture was used.During the suturing on the fascia using an instrument at 3rd ligature, the suture was detached from the needle.It was not a control release needle.There were no adverse patient consequences reported.

• Brand Name: VICRYL SUTURE 36"(90CM) 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: 8704391
• Report Number: 2210968-2019-82815
• Device Sequence Number: 2211480
• Product Code: GAM
• UDI-Device Identifier: 10705031040298
• UDI-Public: 10705031040298
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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
• Report Date (Section B): 05/20/2019

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 Expiration Date: 11/30/2022
• Device Catalogue Number: J474H
• Device Lot Number: LPZ717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/17/2019
• Patient Sequence Number: 1