MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 3-0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y604H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain.Was there any adverse consequence associated with the patient? please provide procedure date.A manufacturing record evaluation was performed for the finished device lot lk6523, and no non-conformances 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.
Event or Problem Description
It was reported that a patient underwent a laparoscopic radical prostatectomy procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture broke while knotting.Changed another one to complete the surgery.The surgery was delayed nearly one hour.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: MCRYL VIO 27IN 3-0 S/A UR-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10326226
• Report Number: 2210968-2020-05590
• Device Sequence Number: 2234659
• Product Code: GAN
• UDI-Device Identifier: 10705031059474
• UDI-Public: 10705031059474
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960653
• 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): 07/17/2020

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: 08/31/2022
• Device Model Number: Y604H
• Device Catalogue Number: Y604H
• Device Lot Number: LK6523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/27/2020
• Patient Sequence Number: 1
• Patient Age: 82 YR