MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 4X24IN(60CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8735
Medical Device Problem Code	Material Separation (1562)
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 a cabg procedure on an unknown date and a suture was used.The surgeon was using a non everpoint needle and that one dulled.A couple months ago he switched to the everpoint.During a cabg he told the rep that the needle kept popping off and the surgeon was applying to much force and switched back to the other product.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6.Component code: g07002 - device not returned.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 information was requested, and the following was obtained: - how many devices demonstrated the alleged deficiency? multiple - unk exact # - did the event occur during one or multiple patient procedures? multiple.- what is the total number of procedures? 15.- please provide the lot number: unk.The boxes are gone.1.Please clarify the product code for dull needle and provide more detail on the occurrence.A.Dull needle only occurred for product code 8735 (stainless steel needle).This only occurred once, and no lot number or further information is possible to obtain.2.Please clarify the product code for pull off and provide more detail on the occurrence.A.Pull off occurred multiple times in multiple procedures with product code epm8735.The sales rep confirmed that the actual number of occurrences and exact number of procedures cannot be provided.He clarified the total number of procedures of 15 was an assumption at the time, however, after further review, the customer has only purchased two boxes of epm8735.The number of occurrences and procedures remains ambiguous.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.

• Brand Name: PROLENE SUT 4X24IN(60CM) 7-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, 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: 21437725
• Report Number: 2210968-2025-01980
• Device Sequence Number: 4349378
• Product Code: GAW
• UDI-Device Identifier: 10705031203662
• UDI-Public: 10705031203662
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• 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): 02/21/2025

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: EPM8735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown