MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y340H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).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.Sample analysis: visual analysis of the returned product revealed that one opened sample product code y340h was received to ethicon inc for evaluation.The strand was broken in several pieces during the inspection due to the degradation process caused by exposure to the environment.The product code y340h contains an absorbable suture.As the package was received open, the time of exposed to the environment could not be determined and functional test cannot be performed.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed.This condition contributed to the degradation of the suture.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.Before use on the patient, it was reported by a sales rep that, during an unknown surgery, when the package was opened, the suture was found to have been torn into several millimeters before use.Upon evaluation of the returned sample, the foil was visually inspected, and excessive wrinkles and holes in the cavity were observed.This condition contributed to the degradation of the suture.No adverse patient consequences were reported.No additional information was provided.

• Brand Name: MCRYL VIO 27IN 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: 14570841
• Report Number: 2210968-2022-04219
• Device Sequence Number: 6113779
• Product Code: GAN
• UDI-Device Identifier: 10705031058866
• UDI-Public: 10705031058866
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

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 Expiration Date: 11/30/2022
• Device Model Number: Y340H
• Device Catalogue Number: Y340H
• Device Lot Number: LPZ225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown