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

Model Number	X425H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional information was requested and the following was obtained: how was the needle retrieved? needle driver used by surgeon.What was done to locate the broken needle in the patient? manual and visual looking.Was x-ray performed? yes.Was there any patient consequence associated with the patient as a result of the device issue? no.Procedure name? lap appy - umbilical repair.Procedure date? (b)(6) 2021.
Event or Problem Description
It was reported that a patient underwent an umbilical repair surgery on (b)(6) 2021 and suture was used.During the procedure, the needle broke in half.Both fragments were retrieved.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 05/19/2021 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.H6 component code: g07002 device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Brand Name: EB EXC GRN 30IN 1 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: 11672661
• Report Number: 2210968-2021-03395
• Device Sequence Number: 11562324
• Product Code: GAT
• UDI-Device Identifier: 10705031057296
• UDI-Public: 10705031057296
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: No Information
• Device Expiration Date: 07/31/2024
• Device Model Number: X425H
• Device Catalogue Number: X425H
• Device Lot Number: PJH836
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/19/2021
• Patient Sequence Number: 1