MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 3-0 D/A SH-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X762H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
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 has been requested and the following was obtained: qty of product involved : 5 - 6.In event description mention " it was found that some sutures had been detached from the needles.Also, some of the sutures were easily detached from the needles" it seems that two different issues occurred, please clarify.Some of sutures were already detached from the needles before use and others were detached during use.Please clarify how many sutures present the issue and confirm quantity for each issue reported.I only know the complaint products are 5 in total.What is the lot number? i certify that all information that are known/available has been disclosed.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: g07002 ¿ device not returned related events captured via 2210968-2023-02426, 2210968-2023-02427, 2210968-2023-02428 2210968-2023-02430, 2210968-2023-02431.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.It was found that some sutures had been detached from the needles.Also, some of the sutures were easily detached from the needles.These were not control release needles.There were no adverse consequences to the patient.Additional information has been requested.

• Brand Name: EB EXC GRN 36IN 3-0 D/A SH-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 16685282
• Report Number: 2210968-2023-02429
• Device Sequence Number: 20830391
• Product Code: GAT
• UDI-Device Identifier: 10705031057920
• UDI-Public: 10705031057920
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: X762H
• Device Catalogue Number: X762H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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