MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 5-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP495H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.The single complaint was reported with multiple events.There are no additional details regarding the additional events.The following information was requested, but unavailable: could you please confirm the quantity of devices that "keep breaking while using the suture" during this single procedure? did 61 individual devices broke during this single procedure? procedure name and date? event date? could you please provide the lot number? (b)(4).
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2021 and the suture was used.During the procedure, the suture keeps breaking while using the suture.There were no patient consequences reported.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/09/2021.H6 component code: g07002 no device problem found.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803.Part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional h3 investigation summary: h3 investigation summary: according to the information received it was reported by the distributor that during an unknown procedure per the customer the product keeps breaking while using the suture.Two sealed boxes and twenty-five packets of product code vcp495h were returned for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packets.In order to evaluate the conditions of thirty-two returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands to detect any issue related to damaged or breakage suture and no defects were observed during evaluation.Functional test was performed, and the tensile strength result were above the minimum requirements.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.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch qkmlej, vcp495h 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 18IN 5-0 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: 12006004
• Report Number: 2210968-2021-05563
• Device Sequence Number: 14278960
• Product Code: GAM
• UDI-Device Identifier: 10705031053748
• UDI-Public: 10705031053748
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: VCP495H
• Device Catalogue Number: VCP495H
• Device Lot Number: QKMLEJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1