MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J417H
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
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.If attempts have been made: 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.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide procedure name and date please provide lot number what was damaged/broken, the packaging or the product? any photos available for visual analysis? please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail.How was procedure successfully completed?.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date in 2021 and suture was to be used.During the procedure, it was discovered that the product is broken/damaged and sterility is compromised.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 27IN 2-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12689555
• Report Number: 2210968-2021-10256
• Device Sequence Number: 4614344
• Product Code: GAM
• UDI-Device Identifier: 10705031039681
• UDI-Public: 10705031039681
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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 Model Number: J417H
• Device Catalogue Number: J417H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1