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	04/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.When was the suture was identified as weak (in the package, during removal from package, during handling or during use on the patient)? please specify.It was stated that the suture was weak, could you please provide more details? was the suture broke or suture detached from the needle? please provide the lot number.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on (b)(6) 2022 and suture was used.The suture was reported as being weak.A like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.

• 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
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14288508
• Report Number: 2210968-2022-03332
• Device Sequence Number: 20185505
• Product Code: GAT
• UDI-Device Identifier: 10705031057296
• UDI-Public: 10705031057296
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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: X425H
• Device Catalogue Number: X425H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown