MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 5-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number VCP493H

Device Problems Material Separation (1562); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # pc-(b)(4).Date sent to the fda:(b)(6)/2022 h6 component code: g07002 - device not returned 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, 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 was requested, the following was obtained: were there any unexpected outcomes or complications as a result of the prolonged surgery time? - no.What tissue was being sutured when the event occurred?-subcutaneous tissue of the ear.Was additional dissection required in other organs/tissues other than the target tissue? -no.Was there any change in the patient¿s post operative care due to the prolonged procedure? -unk.What tissue structure the broken needle was located? -subcutaneous tissue of the ear.Was there any additional tissue damage as a result of searching for the needle piece? the subcutaneous tissue of the ear was cut to retrieve the needle.What is the current status of the patient? -good.Please provide the lot number: scmlcl.Device return status: local cq will follow the device return per sop.The procedure should be ear malformation plastic surgery.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.Trade name - irgacare.Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength -= 275 ¿g /m.Related reports: (b)(6), (b)(6), & (b)(6).

Event Description

It was reported that a patient underwent a ear malformation plastic surgery procedure on (b)(6)2022 and suture was used.During the procedure, the pull off suture needle occurred when stitching.Changed another one to continue but the same issued occurred.Changed the 3rd one to continue, but needle did not penetrate the tissue after stitching, the doctor pulled back the suture and tried to pull the needle out.The pull off suture needle appears and the needle was stuck in the tissue.The x-film was used to position the needle and the tissue was cut to remove the needle.The surgery was extended by about 1 hour.Changed a new product to complete the procedure.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 01/03/2023.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 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.H3 investigation summary:the product was returned for evaluation.Visual inspection was conducted on the returned sample.Visual analysis of the returned samples revealed that it was received one empty open foil, one detached needle, and a suture piece that pertained to product code vcp493h.In order to evaluate the conditions of the detached needle, marks by a surgical instrument could be observed on the tip, the swage area, and hole of the needle.In the hole was observed a suture piece.In addition, the suture was examined, and the end was noted to be cut probably caused by a surgical instrument.The instructions for use contain the following: to avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 1/18/2023.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, 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 was requested, the following was obtained: the needle-suture piece does not belong to the product code vcp493.Please let us know what product code and lot number this belongs to? unk.Does this needle-suture piece relate to this complaint? no.Was this needle-suture piece returned in error or belong to another complaint? returned in error.

• Brand Name: VCL+ UD 18IN 5-0 S/A P-3 PRM MP
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15932778
• MDR Text Key: 307903742
• Report Number: 2210968-2022-10055
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031053663
• UDI-Public: 10705031053663
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K032420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2023

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
• Device Operator: Health Professional
• Device Model Number: VCP493H
• Device Catalogue Number: VCP493H
• Device Lot Number: SCMLCL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 01/04/2023
• Supplement Dates FDA Received: 01/03/2023; 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1