MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 24"(60CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8805
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent a pediatric cardiovascular procedure on (b)(6) 2022 and suture was used.During procedure the sutures were 'falling off.No other information is available at this time.No adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional information has been requested and received.Was the needle piece removed from the patient during the same procedure? no.Was there any additional tissue damage as a result of searching for the needle piece? was additional dissection required in other organs/tissues other than the target tissue? no, but the surgeon was very upset because he had to start the case over.What is the most current patient health status and condition? no.Procedure date? (b)(6) 2022.Lot number? no.Device return status/follow up? suture used in (b)(6) 2022 was not set aside to be returned.Dr.Said, ¿this is happening to many of us.It is certain lot numbers and batches.The swage is not connected to the suture properly.In my cases, i have to take 30 bites.On the 12th bite, the needle disconnects from the suture.This happens in batches.Three of my sutures broke.It¿s not swaged correctly.This is not the needle holder issue.This is not a torque issue either.It is tissue agnostic.¿ the nurse said, ¿surgeon takes one pass and the needle snaps off.Surgeon takes 2 & 2 passes and the needle snaps off.¿ additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent.The date reported is feb 10, however you responded the date of surgery was feb.11.Please clarify.Please obtain detailed information and advise of other events from other surgeons.No product is available for return.Note: events reported on mw# 2210968-2022-01616, mw# 2210968-2022-01617, mw# 2210968-2022-01618.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 SUTURE 24"(60CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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
• MDR Report Key: 13714584
• Report Number: 2210968-2022-01619
• Device Sequence Number: 6373694
• Product Code: GAW
• UDI-Device Identifier: 10705031046238
• UDI-Public: 10705031046238
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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 Model Number: M8805
• Device Catalogue Number: M8805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown