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

Model Number	Y340H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - 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.H3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.The returned sample revealed that it was received one labeled winding former with some suture pieces in the degradation process and one detached needle that pertains to the product code y340h.As per visual inspection of the sample, it was observed that the strand has begun with a degradation process caused by exposure to the environment.This condition contributes to the needle separating from the suture.In addition, the foil was not returned for evaluation.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The following information was requested, but unavailable: what is the lot number? unk.The manufacturing records couldn't be reviewed as the batch number is unknown.
Event or Problem Description
It was reported that a patient underwent a ob-gyn procedure on (b)(6) 2023 and suture was used.During the procedure it was reported by a sales rep that, during an unknown ob-gyn surgery, after opening the package and before use, it was found that the suture had been detached from the needle.It was not a control release needle.Visual inspection evaluation was conducted on the returned device.The returned sample revealed that it was received one labeled winding former with some suture pieces in the degradation process and one detached needle that pertains to the product code y340h.As per visual inspection of the sample, it was observed that the strand has begun with a degradation process caused by exposure to the environment.This condition contributes to the needle separating from the suture.No adverse patient consequences were reported.Additional information was requested.

• 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.; 1000 route 202; raritan 08869
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17021186
• Report Number: 2210968-2023-03913
• Device Sequence Number: 6872362
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2023

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: Y340H
• Device Catalogue Number: Y340H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown