MAUDE Adverse Event Report: ETHICON INC. MONOCRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y426H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 5/16/2026.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.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: (b)(4): case 1.Product y426h, lot #: 1027ck.(b)(4): case 2.Product: g122, lot #: unk.What instruments were used to grasp the needle? where was the needle grasped during use? were x-rays performed to localize the needle fragment? what was the size of the broken needle fragment? where did the needle break (tip, middle, swage area)? were the needle piece(s) retrieved during the same procedure? does the piece/device remain retained in the patient¿s tissue? if the piece(s) were retained, where are they located/in what structure? if retained, are there plans for removal of any remaining fragments? if so, could you please provide the scheduled date for the removal? lot #: 1027ck is not recognized, could you please confirm the lot number for y426h? could you please provide the lot number for product g122? please provide the source or name of person providing answers to follow-up questions: 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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
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 in 2 cases they had a needle break.An x ray was done but were not able to be found.There was no issues with the patients.Device is not available for return.Additional information was requested.

• Brand Name: MONOCRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25201902
• Report Number: 2210968-2026-05466
• Device Sequence Number: 13285975
• Product Code: GAN
• UDI-Device Identifier: 10705031059146
• UDI-Public: 10705031059146
• 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

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: 1027CK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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