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 suture was used.It was reported the surgeon who was doing an in-service yesterday in the break room at the hospital.It was approached by a nurse, who expressed her frustration about needles being hard to see and getting dropped.She was wondering if i had any ideas on how to store these needles when not in use during cases.The rep told her to cut the suture tail longer, so the dyed suture and needle are visible, making it easier to see and also suggested a needle boot to hold the needle.She mentioned during a cabg procedure that day that the everpoint needle was dropped.Surgery was paused and finally after some time looking for the suture, they called x-ray.She said x-ray showed no signs of needle.Surgery resumed and needle was never found.The rep was asked how many times the needle has been dropped in cases.She said at least five or six times in the last couple months.The surgeon told her that would report this event through our hotline and follow up with her.The procedure was delayed by sixty minutes.The procedure was completed successfully with no adverse consequences for the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 10/15/2025.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.Additional information was requested the following was obtained: please provide an answer for each case: (b)(4) is for incident #1, (b)(4) is for incident #2, (b)(4) is for incident #3, (b)(4) is for incident #4, (b)(4) is for incident #5, (b)(4) is for incident #6.Were there any adverse consequences for the patient in the other 5 procedures that occurred over the last couple of months? could you provide more details on why the everpoint needles are dropping in patients? is the needle falling off because it was pulled off the suture, or is it because the suture is breaking? please provide more details.During the other 5 procedures that occurred over the last couple of months: was the needle retrieved during the same procedure? was there any additional tissue damage resulting from the search for the needle? were there any extensions of the surgery in the other 5 procedures that occurred over the last couple of months? if yes, were there any unexpected outcomes or complications resulting from the prolonged surgery time? how long, in minutes, did the surgery prolong? which tissue was being sutured when the event occurred? was additional dissection required in other organs/tissues other than the target tissue? was there any change in the patient¿s post operative care due to the prolonged procedure? could you please provide the lot number? please provide the source or name of person providing answers to follow-up questions: i don¿t have any additional details to share with you.This was reported to me, and i was not in those cases.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: as the lot number for the device involved in the event was not provided, the full udi is currently not available.

• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23311536
• Report Number: 2210968-2025-11937
• Device Sequence Number: 17596060
• Product Code: GAW
• UDI-Device Identifier: 10705031203662
• UDI-Public: 10705031203662
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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: 09/25/2025
• Initial Report FDA Received Date: 10/16/2025
• 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