MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 0 S/A CT-1; SUTURE, NONABSORBABLE, SILK

Model Number	424H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.(b)(4).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.Note: events reported in 2210968-2021-09900, 2210968-2021-09901, 2210968-2021-09902, and 2210968-2021-09903.
Event or Problem Description
It was reported that the patient underwent a cardiovascular procedure on (b)(6) 2021 and suture was used.During the procedure, at the time of making the stitch, the suture weakened and broke in half.The surgery was delayed by 10 minutes.Another suture was used and the procedure was completed successfully.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: SILK BLK 30IN 0 S/A CT-1
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12656992
• Report Number: 2210968-2021-09903
• Device Sequence Number: 4852863
• Product Code: GAP
• UDI-Device Identifier: 10705031005327
• UDI-Public: 10705031005327
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K946173
• 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
• Report Date (Section B): 10/19/2021

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: 08/31/2025
• Device Model Number: 424H
• Device Catalogue Number: 424H
• Device Lot Number: AN9271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1
• Patient Age: 65 YR