MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 36IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP945H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a c-section procedure on (b)(6) 2025 and suture was used.It was reported to the sales rep that during c-section, while suturing, the needle tip broke off.No patient consequences.Device is returning.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/26/2025.H6 component code: g07002 - device not returned.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.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 confirm which device is malfunctioning: mcp945 or mcp944? - was the needle tip retrieved during the same procedure? - were x-rays taken to locate the needle tip? - what measures were implemented to retrieve the broken tip? - was there any additional tissue damage resulting from the search for the needle tip? - please provide the source or name of person providing answers to follow-up questions: additional information was requested, the following was obtained: - could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided sorry for the delay this was shipped back today.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 received for analysis was identified as product code mcp945h.Visual inspection and metallurgical analysis were performed on the returned product.A blunt tip was observed.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.A blunt tip was noted, but fractographic features indicative of a failure mode were not observed.The evaluation of (b)(4) revealed the needle contained a blunt tip.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance., h3 investigation summary: the product was returned to ethicon for evaluation.One representative unopened sample was received for analysis.Product code mcp945h.The complaint sample was not received for evaluation.Upon initial inspection of the sample, no external damage was observed on the external packet.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted to be as expected.The tip and body of the needle were examined under magnification and no defects or needle breakage were found.In addition, the sample was tested by resistance test to needle and met the requirements.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.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.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.H3 investigation summary: the product was returned to ethicon for evaluation.One representative unopened sample was received for analysis.Product code mcp944h.The complaint sample was not received for evaluation.Upon initial inspection of the sample, no external damage was observed on the external packet.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted to be as expected.The tip and body of the needle were examined under magnification and no defects or needle breakage were found.In addition, the sample was tested by resistance test to needle and met the requirements.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.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.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: MCRYL+ UD 36IN 2-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22336361
• Report Number: 2210968-2025-07468
• Device Sequence Number: 21113685
• Product Code: GAM
• UDI-Device Identifier: 10705031046795
• UDI-Public: (01)10705031046795(17)261130(10)105GJA
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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 Catalogue Number: MCP945H
• Device Lot Number: 105GJA
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2024
• 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