MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 1 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y399H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that the needle broke on both products during the procedure.The tip of the needle was not retrievable, they have a photo also.There is no adverse impact on patient/user reported.Devices are available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 11/3/2025.H6 component code: g07002 - pending evaluation of returned device.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.A device has been received; however, clarification is requested whether the product belongs to this complaint.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: product code: z358t, product lot #/batch: 106st5, tracking #: (b)(4), (b)(6), received at cg labs on 10/30/2025.1.Could you please clarify if extra device belongs to this complaint? 2.If not, could you please clarify if the extra received products belong to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.Additional information was requested; the following was obtained: were x-rays taken to locate the needle piece(s)? no, tip of suture needle recovered was there any additional tissue damage as a result of searching for the needle piece(s)? no is there any plan in place to remove the needle piece in the future? if so, could you please provide the scheduled date for the removal? no what is the surgeon's opinion of the potential consequences for the patient? potential for sentinel event with sharp object left inside patient.Was there any additional tissue damage resulting from the search for the needle pieces? no additional tissue damage noted what is the current status of the patient? home recovering from surgery please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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.Additional information: h6, d9, h3.Corrected data: e1, d4, udi and initial reporter.H3 investigation summary: the product was returned to ethicon for evaluation.Five (5) unopened samples that pertain to product code y399.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted as expected.The tip and body of the needles were examined under magnification and no anomalies or issues related to needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.A photo was provided showing a needle suture broken at the tip area.As part of the 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 information was requested, the following was obtained: 1.Could you please clarify if extra device belongs to this complaint? the suture in the complaint come from those boxes and lots.2.If not, could you please clarify if the extra received products belong to a different complaint? if so, can you please provide the complaint number.No, the boxes were sent because the suture come from those boxes.3.If the device was not reported before, please provide more details of device malfunction.This is not a new complaint as explained above 4.If the product doesn t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.The boxes of suture you received were where the complaint sutures come from.See the attached email.No needle was left in the patient as the complaint department described in the attached email.The tip of the needle was removed from the patient before the incision was closed.Also, no one ever responded to my attached request to speak with someone in the complaint department.

• Brand Name: MCRYL VIO 36IN 1 S/A CTX
• 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: 23451259
• Report Number: 2210968-2025-12425
• Device Sequence Number: 20825399
• Product Code: GAN
• UDI-Device Identifier: 10705031059108
• UDI-Public: (01)10705031059108(17)300430(10)108BCJ
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• 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): 12/02/2025

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: Y399H
• Device Lot Number: 108BCJ
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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