MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 0 S/A CT-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X424H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4) device not returned.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: what was the procedure date? (b)(6) 2021.Was the needle piece retrieved during the same procedure?- none was ever found.What tissue structure the broken needle was located? can not confirm the needle broke in tissue, suture was used to close back tissue s/p spinal cord stimulator insertion.Device return status: was disposed of in sharps.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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.
Event or Problem Description
It was reported by the facility that during a spinal implant procedure, the suture needle was difficult to pass through the tissue and the needle tip was not present.An x-ray was completed and there was no partial needle or part of supply left in patient.There were no patient consequences reported.It is unknown if device is available for return.

• Brand Name: EB EXC GRN 30IN 0 S/A CT-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12544887
• Report Number: 2210968-2021-08951
• Device Sequence Number: 19841519
• Product Code: GAT
• UDI-Device Identifier: 10705031057272
• UDI-Public: 10705031057272
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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 Expiration Date: 11/30/2025
• Device Model Number: X424H
• Device Catalogue Number: X424H
• Device Lot Number: QPBARJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1