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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number phk987/ y604h39, and no non-conformances 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 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.Could you please confirm if the patient suffer from any consequence due to the issue (breakage suture)? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent laparoscopic appendectomy on (b)(6) 2020 and suture was used.The suture broke when sewing the incision at the time of knotting in the surgery.Changed to another device to complete the surgery.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 2/3/2021 the following information was requested, but unavailable: could you please confirm if the patient suffer from any consequence due to the issue (breakage suture)? unobtainable 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.

• 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: 11051796
• Report Number: 2210968-2020-10159
• Device Sequence Number: 16457980
• 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
• 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): 12/04/2020

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: 06/30/2024
• Device Model Number: Y604H
• Device Catalogue Number: Y604H
• Device Lot Number: PHK987
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/03/2021
• Patient Sequence Number: 1
• Patient Age: 38 YR