MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A UR-5; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP376H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: what was the size of the needle used? vicryl ur-5 vcp376 lot #qhmjxm exp.6/30/2025.Was more than half the needle retained in the patient? no.Where is the needle retained; in what structure? fascia off iliac crest.Are there plans to remove the retained needle piece? no.Could you please provide the procedure name? xi laparoscopic assisted right partial nephrectomy.Patient¿s current status? great.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.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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 275 g/m.
Event or Problem Description
It was reported that a patient underwent a nephrectomy surgery on (b)(6) 2021 and suture was used.During the procedure, per user facility medwatch form, mw5099954, "surgeon was using the suture when part of the needle broke at approximately 1400 in operating room 10.Surgeon was aware that part of the needle remained inside of the patient.Surgeon attempted to retrieve item, but item was not found.Surgeon determined it would be more traumatic to the patient to dissect tissue to remove the needle.At closing of procedure, another attempt was made to locate item.Item was still not found.Device is not available for return.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 0 S/A UR-5
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11737916
• Report Number: 2210968-2021-03911
• Device Sequence Number: 16901357
• Product Code: GAM
• UDI-Device Identifier: 10705031052895
• UDI-Public: 10705031052895
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• 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): 04/06/2021

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: 06/30/2025
• Device Model Number: VCP376H
• Device Catalogue Number: VCP376H
• Device Lot Number: QHMJXM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1