MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y346H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a spaying & neutering procedure in 2022 and suture was used.During the procedure, the suture broke.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device not returned.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.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 via: was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? during use.Lot number? lot qmmbuh; lotrjmqdh; lot rcmbtj.Procedure and event date? (b)(6) 2022, mass removal, y346h (lot qmmbuh); (b)(6) 2022, mass feline ovh, y316h (lot rcmbtj); (b)(6) 2022, canine neuter, y317h (lotrjmqdh); (b)(6) 2022, canine ovh, y317h (lotrjmqdh), (b)(6) 2022, feline ovh, y316h (lot rcmbtj); (b)(6) 2022, canine ovh, y346h (lot qmmbuh); (b)(6) 2022, canine neuter, y317h (lotrjmqdh).Are any samples available of evaluation? we have the remainder of the box but none of the specific sutures were retained.Possible lot number involved lot: qmmbuh; lotrjmqdh; lot rcmbtj.Events reported via: 2210968-2022-04155.
Additional Manufacturer Narrative
Product complaint # (b)(4).The actual device lot number associated with this event is not known.The possible lot numbers are reported as follows: batch qmmbuh mfg date: 11/9/2020, exp date: 10/31/2025.Batch rcmbtj mfg date: 3/4/2021, exp date: 2/28/2026.Batch rjmqdh mfg date: 8/27/2021, exp date: 7/31/2026.A manufacturing record evaluation was performed for the finished device qmmbuh/ y346h55 batch number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device rcmbtj / y346h06 batch number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device rjmqdh/ y346h50 batch number, and no non-conformances were identified.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 36IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14551570
• Report Number: 2210968-2022-04154
• Device Sequence Number: 5172680
• Product Code: GAN
• UDI-Device Identifier: 10705031058910
• UDI-Public: 10705031058910
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: Y346H
• Device Catalogue Number: Y346H
• Device Lot Number: QMMBUH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown