MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 D/A V-5 10PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	D10068
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.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: please confirm: how many sutures experienced pull off suture needle during this procedure? --one product code and lot number? --w8557 / lot remkrc please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? what instruments were used to grasp the needle? where was the needle grasped during use? please describe any medical/surgical intervention required for this suture event including dates and results.Was the needle removed 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? was additional dissection required in other tissues other than the target tissue? if yes, please describe.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? were there any adverse patient consequences caused by the prolonged duration of extracorporeal circulation? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? --contacted with the sales rep today via phone, please refer to the event description and other information requested is unknown.
Event or Problem Description
It was reported that a patient underwent a heart valve replacement procedure in (b)(6)2023 and suture was used.The patient was admitted to the hospital due to "exertional chest tightness and shortness of breath for 3 years, worsening for half a month" and underwent surgery.During the surgery, the doctor used the suture to fix the artificial heart valve, when the needle was sewn through the heart and the artificial valve and threaded out, the needle pulled off the suture and the needle fell into the pericardium.It was not found at that time.Further information provided stated that after continuing to sew the artificial heart valve with other suture for one loop, when preparing to tie and fix the artificial heart valve one by one, it was found that a needle was missing from the thread, and the search began, after c-arm x-ray fluoroscopy localization, it was found in the pericardium that the connection between the tail of the needle and the head of the suture was unstable and detached, and no artificial shortening or tearing marks were found.This event affected the surgical process and prolonged the duration of extracorporeal circulation, which may exacerbate the damage caused by the patient's extracorporeal circulation surgery.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information: h6 type of investigation code.Additional information was requested, and the following was obtained: the surgery time was prolonged for about 2 hours due to this event.The patient has been discharged smoothly currently.No subsequent adverse event report was received.
Additional Manufacturer Narrative
(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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, and the following was obtained: lot number remkrc corresponds to the product code d1006819 not w8557.What is the correct product code? w8557.What is the correct lot number? unk.
Additional Manufacturer Narrative
(b)(4) 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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, and the following was obtained: according to feedback of the sales rep, product code should be d10068 , lot number should be remkrc.(b)(4).

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 D/A V-5 10PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17105960
• Report Number: 2210968-2023-04227
• Device Sequence Number: 14161623
• Product Code: GAT
• UDI-Device Identifier: 10705031134416
• UDI-Public: 10705031134416
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/25/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: D10068
• Device Catalogue Number: D10068
• Device Lot Number: REMKRC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 06/30/2023; 07/11/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/27/2023; 07/07/2023; 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male