MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 8X18IN 1 S/A CTXB CR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	D9498
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The following information was requested, but unavailable: could you please provide the lot number? no further information is available.No further information will be provided.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.(b)(4).
Event or Problem Description
It was reported that a patient underwent an abdominal aortic aneurysm surgery on (b)(6) 2021 and suture was used.The needle was detached from the suture during interrupted suturing on the fascia.It was a control release needle.There were no adverse consequences to the patient.No further information is available.

• Brand Name: EB EXC GRN 8X18IN 1 S/A CTXB CR
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11980005
• Report Number: 2210968-2021-05446
• Device Sequence Number: 19176129
• Product Code: GAT
• UDI-Device Identifier: 10705031033306
• UDI-Public: 10705031033306
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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: D9498
• Device Catalogue Number: D9498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/10/2021
• Patient Sequence Number: 1