MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 6-0 D/A TG100-8; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J544G
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device number ppmbtk / j544g, and no non-conformances related to the reported complaint condition were identified.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: please clarify what means "there was a tie in the middle of the suture" suture was fraying? ans - after reconfirmation of the status, there were weaken yarn in the middle.Please ref.Attached pic.A photo upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, it was noted that there was a tie in the middle of the suture.New pack opened to use.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4) date sent to fda: 02/01/2021.Additional information: h6 h3 photo analysis: a picture was received for evaluation.Upon to visual inspection of the picture, an opened folder with a partially dispensed suture with an open filament could be observed.No conclusion could be reached as on what caused the reported complaint, since the sample was not returned for analysis.H6 investigation findings: c22 - 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.

• Brand Name: VCL CT BRD VIO 18IN 6-0 D/A TG100-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11124616
• Report Number: 2210968-2021-00077
• Device Sequence Number: 17082828
• Product Code: GAM
• UDI-Device Identifier: 10705031041073
• UDI-Public: 10705031041073
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K022269
• 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): 12/08/2020

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: 11/30/2024
• Device Model Number: J544G
• Device Catalogue Number: J544G
• Device Lot Number: PPMBTK
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1