MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y922H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.Before use on the patient, it was reported by the user facility that during an unknown procedure, the suture was only half the length it should have been when removed from the suture package.There were no patient consequences reported.No additional information was provided.
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: visual analysis of the returned product revealed that one opened sample product code y922 was received for evaluation.Upon visual inspection of the returned sample, the suture end was observed to have damaged and was broken due to stress applied.In addition, no damaged caused by surgical instrument or use were observed.The length suture was measured and did not meet the requirement due to returned condition of the sample.The damaged suture defect has been correlated to the manufacturing process.Based on the information currently available, the damaged suture defect was identified during the investigation of the sample received.This product issue will be addressed through quality system.

• Brand Name: MCRYL VIO 36IN 4-0 S/A FS-2
• 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: 12868620
• Report Number: 2210968-2021-12046
• Device Sequence Number: 5942355
• Product Code: GAN
• UDI-Device Identifier: 10705031059856
• UDI-Public: 10705031059856
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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 Expiration Date: 04/30/2026
• Device Model Number: Y922H
• Device Catalogue Number: Y922H
• Device Lot Number: REMHHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2021
• 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