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

Catalog Number	X951H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 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.Attempts have been made to retrieve the device.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.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.It was reported that "so far 7 have been affected." * please confirm if 7 devices had the issue during one procedure or if multiple procedures were affected.If multiple procedures, please confirm the quantity of sutures that separated during each procedure.* when did the needle detach/pull off from the suture (in the package, during removal from the package, during handling before use on patient or during use on the patient)? please specify * 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) a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, it was reported to the distributor by the customer that the suture is separating from needle at swage.It is unknown if there were any patient consequences.The device is available for return.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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.H3 investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample revealed that it was received one detached needle and one suture that pertained to product code x951h.In order to evaluate the conditions of the detached needle, the swage and attachment area were as expected.Marks on the edge needle that appears to be by a surgical instrument could be observed.The hole was examined under magnification and a remnant of suture was observed.In addition, the suture was inspected, excessive body fluids and the extremes were noted to be cut probably caused by a surgical instrument.The instructions for use contain the following caution: to avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional information was requested, and the following was obtained via: i am taking the time to answer the questions posed in your last email to our office.1.2.Please confirm if 7 devices had the issue during one procedure or if multiple procedures were affected.If multiple procedures, please confirm the quantity of sutures that separated during each procedure? a.The issues have resulted during multiple procedures.On average 2-4 sutures have separated at the same spot (connection between the suture and needle).It has been a total of 17 sutures (not 7) that this has occurred with.When did the needle detach/pull off from the suture? a.The needle generally detached during the process of the passing through the tissue for the first or second time.It was not in the removal of the suture from the packaging.B.There were no patient consequences.We have been ordering this specific suture for 30 years and have never had this issue continue to arise.

• Brand Name: EB EXC GRN 30IN 5-0 S/A V-5
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18557018
• Report Number: 2210968-2024-00586
• Device Sequence Number: 6469210
• Product Code: GAT
• UDI-Device Identifier: 10705031058439
• UDI-Public: 10705031058439
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: X951H
• Device Lot Number: SJMEDH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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