MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X27IN 0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPP41D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: please provide procedure name spine.Please explain in detail what was the issue with the device.What do you mean by ¿the pop off came off too easily¿? do you mean the suture and the needle become separated(suture - needle pull off)? yes.Please provide lot number not exactly sure of the lot number but i do have the container the suture was in and the lot information of the one they used ao replace this which might be the same one i¿m not sure.Please provide status of product return i have product just waiting for the packaging to return it.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 spine procedure on (b)(6) 2021 and suture was used.During the procedure, the pop off came off too easily.The suture and the needle become separated.The procedure was completed with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Date sent to the fda: 8/25/2021 this report is being submitted pursuant to the provisions of 21 cfr, part 803.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, or its employees that the report constitutes an admission that the product, ethicon, 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 information: h6, d9,h3 h3 investigation summary: a winding former with five strands product code vcpp41d with the needles unused.In order to evaluate the conditions of the returned samples, the swage and attachment area was noted to be as expected in the five needles.The sutures were dispensed without problems and examined along the strand to detect any issue on the suture and no defects were observed during evaluation.Functional test was performed, and the pull force meets the customer requirements.The manufacturing records couldn't be reviewed as the batch number is unknown.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL+ UD 8X27IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12229668
• Report Number: 2210968-2021-06690
• Device Sequence Number: 14487357
• Product Code: GAM
• UDI-Device Identifier: 10705031056848
• UDI-Public: 10705031056848
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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 Model Number: VCPP41D
• Device Catalogue Number: VCPP41D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/25/2021
• Patient Sequence Number: 1