MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y426H
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 in 2025 and suture was used.During the procedure, it was reported by the sales rep that during an unspecified procedure, the needle is shearing and breaking off.There were no patient consequences reported.Device is available for return.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).H6 type of investigation: b21 - device evaluation pending.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.The device 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: 1.Could you please clarify if extra device belongs to this complaint? yes it was submitted with the suture that was initially called in.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.N/a.3.If the device was not reported before, please provide more details of device malfunction.I received the same information for this device as the previous.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.They did not make me aware that another lot # was affected.What does "the needle is shearing" mean? please provide additional details.My understanding is that the tip of the needle was breaking off.Are there photos available for visual analysis? the needles have been sent in.The tracking number is (b)(4).When is ''the needle is shearing'' (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? to my understanding, it is during handling when passing the needle through tissue.When did the needle detach/pull off from the suture thread (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during handling.Provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).(b)(6) (please refer to the attached email) or coordinator.
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.Additional information: h6, d9, h3.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one empty foil and one needle suture piece were received for analysis.Product code y426h.A visual inspection was performed on the returned sample, and the swage and attachment area were noted to be as expected.The tip and body of the needle were examined under magnification and no anomalies or issues related to needle breakage were found.The sample was tested by resistance test to needle and met the requirement.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 to one-half of the distance from the attachment end to the point.Please reference the instruction for use for more information.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.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.

• Brand Name: MCRYL UD 27IN 4-0 S/A PS-2 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; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23728528
• Report Number: 2210968-2025-13640
• Device Sequence Number: 21386488
• Product Code: GAN
• UDI-Device Identifier: 10705031059146
• UDI-Public: (01)10705031059146(17)300331(10)107JQC
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• 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): 12/12/2025

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: Y426H
• Device Lot Number: 107JQC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2025
• 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