MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 4-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	X557H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following additional information was requested, the following was obtained: -when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify - please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).--contacted with the sales rep today via phone, please refer to the event description and other information requested is unknown.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.Related reports: (b)(4).
Event or Problem Description
It was reported that a patient underwent an excision of brain tumors surgery on (b)(6) 2023 and suture was used.During the procedure, problem of pulling off suture needle happened in the excision of brain tumors surgery.Changed another nine to continue the surgery, the same problem happened.Changed another one to complete the surgery.The needle did not fell into the patient.There were no patient consequences reported.Additional information was requested.

• Brand Name: EB EXC GRN 36IN 4-0 D/A RB-1
• 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: 18012980
• Report Number: 2210968-2023-07350
• Device Sequence Number: 12591171
• Product Code: GAT
• UDI-Device Identifier: 10705031057562
• UDI-Public: 10705031057562
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2023

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: X557H
• Device Lot Number: SGMJPQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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