MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP427H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a laparoscopic appendectomy procedure on (b)(6) 2021 and suture was used.During the procedure, the needle broke while in the tissue.An x-ray was ordered, and the needle was successfully identified and removed from the tissue.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being 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: was the needle piece(s) retrieved during the same procedure? yes.The broken piece of the needle was identified on x-ray and retrieved from the patient's tissue during the same procedure.The needle broke in two pieces.Was there any additional tissue damage as a result of searching for the needle piece? unknown did the surgery was successfully completed? yes.The surgery was successfully completed.What was used to complete the surgery? a 3-0 vicryl suture.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 275 ¿g/m.

• Brand Name: VCL+ UD 27IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12649233
• Report Number: 2210968-2021-09811
• Device Sequence Number: 19117771
• Product Code: GAM
• UDI-Device Identifier: 10705031053151
• UDI-Public: 10705031053151
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: VCP427H
• Device Catalogue Number: VCP427H
• Device Lot Number: QK2AKJ
• 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: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1