MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y333H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2024 and suture was used.It was reported that two needles broke off into the patient.This happened on (b)(6) 2024 unsure when it actually happened 2 different incidents where the needle broke off into patient.There were no adverse consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4) h6 component code: g07002 - device not returned.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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: please confirm if two needles broke off during 1 procedure or if two procedures/patients were affected by 1 case of needle breakage each.Did the needle break into separate pieces or did the entire needle detach/pull off from the suture.How were the needle pieces retrieved from the patient? were there any patient consequences? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep is this device or samples from the same lot available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone numbe 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.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 2-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20856103
• Report Number: 2210968-2024-12905
• Device Sequence Number: 20980524
• Product Code: GAN
• UDI-Device Identifier: 10705031058798
• UDI-Public: 10705031058798
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 12/05/2024

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: Y333H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/05/2024
• 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