MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP494G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a skin cancer excision procedure on 05/04/2022 and suture was used.During the procedure, two lots of sutures from batch mcp494 broke during use.In both cases the needle snapped off from the suture material.No adverse patient consequences were reported.Additional information was requested.
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.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.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.Photo analysis: visual analysis of the picture received for evaluation determined that open foil packet of product code mcp494g could be observed.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 part of our quality process, manufacturing records for this batch serial number were reviewed and manufacturing standards were met prior to the release of this batch.No conclusion could be reached on the cause of the reported complaint, as the sample was not returned for analysis.As part of ethicon's quality process, all devices are manufactured, inspected, and released to approved specifications.Additional information was requested, and the following was obtained via: did the suture break during the procedure? or did the needle separated from the suture during the procedure? the material broke away from the needle while pulling through the skin.What tissue was being approximated/ sutured? back and arm.Were x-rays performed to localize the needle? not needed.Was the needle removed from the patient? needle was in the needle holder.Was the procedure completed successfully? yes.Was there any adverse patient outcome? no.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.Event reported via: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 06/22/2022 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.H3 investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Eleven packets and two empty opened foils of product code mcp494g were returned for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packet.In order to evaluate the conditions of the returned samples, the eleven packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issues related no defects observed during the evaluation.Functional test was performed, and the pull force result were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested, and the following was obtained: did the suture break during the procedure? or did the needle separated from the suture during the procedure? the material broke away from the needle while pulling through the skin what tissue was being approximated/ sutured? back and arm were x-rays performed to localize the needle? not needed was the needle removed from the patient? needle was in the needle holder was the procedure completed successfully? yes was there any adverse patient outcome? no this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m event reported via: 2210968-2022-04086.

• Brand Name: MCRYL+ UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: 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
• MDR Report Key: 14499068
• Report Number: 2210968-2022-04087
• Device Sequence Number: 5106056
• Product Code: GAM
• UDI-Device Identifier: 10705031046573
• UDI-Public: 10705031046573
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: 06/30/2023
• Device Model Number: MCP494G
• Device Catalogue Number: MCP494G
• Device Lot Number: RHMPMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown