MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP215H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Could you please provide the lot number? 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.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.(b)(4).
Event or Problem Description
It was reported that a patient underwent a knee amputation procedure on (b)(6) 2021 and suture was used.During the procedure, it was reported by the sales rep that during an above the knee amputation while suturing subcutaneously in fascia the needle popped off of two sutures.They were retrieved.A new suture was used to complete the case with no consequences.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Analysis summary: product was returned to ethicon inc for evaluation.Visual analysis of the returned sample determined that an unopened sample of product code vcp215h was received for evaluation.Visual analysis of the returned sample and no defects were found on the package.The sample was opened, the swage and attachment area was noted to be as expected.The suture was dispensed without problems and examined along the strand and no defects or damage were observed.A functional test was performed using an instron and the pull force was above the minimum requirements.The device performed without any defect noted and the actual complaint sample was not returned for analysis.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.(b)(4).

• Brand Name: VCL+ UD 27IN 3-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11807263
• Report Number: 2210968-2021-04438
• Device Sequence Number: 14311770
• Product Code: GAM
• UDI-Device Identifier: 10705031051683
• UDI-Public: 10705031051683
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 11/30/2025
• Device Model Number: VCP215H
• Device Catalogue Number: VCP215H
• Device Lot Number: QPMHAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1