MAUDE Adverse Event Report: U&I CORPORATION ANAX 5.5 CT SPINAL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	CT0010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On february 12th of 2021, during the spinal fusion surgery, the thread of the ct driver's distal tip where a screw is conjunct with its head broke off while inserting the screw into the patient.Based on the design intention, a user should conduct threading after making sure the hex part fully connects to the screw.However, if the user doesn't make the hex part of the driver's distal tip not fully projected enough to be connected to the screw, the thread part could be broken during inserting the screw as the stress concentrates on only the thread part.So the thread part of the driver may be broken.Concerning it, we gave the user the precautions for assembling the instrument components.Although this problem occurred for the first time resulting from the user error, we determined to change the design of the driver to complement voluntarily even to that extent.So we don't need the recall process.Besides, the thickness of the same lot(19i09040)'s thread part in the distal tip was measured to see the possibility of nonconformity in the manufacturing process and we confirmed the conformity.
Event or Problem Description
Inserted threads broke off into the inserter, it is not able to advance the screw in anymore or remove cause the threads broke in the screw.The threads seared off inside of the screw, the screw was fine the surgeon just was not able to advance the screw anymore nor was he able to take it out because the threads were still screwed inside the screw head.He needed to screw a couple more turns but it was ok and down enough he could work with it.The broken thread left inside of the screw head.

• Brand Name: ANAX 5.5 CT SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): U&I CORPORATION; 20, sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 11735786
• Report Number: 9617297-2021-00007
• Device Sequence Number: 11641541
• Product Code: HXX
• UDI-Device Identifier: 08800015999854
• UDI-Public: (01)08800015999854(11)190921(10)19I09040
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: 505
• Remedial Action: Patient Monitoring,Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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 Model Number: CT0010
• Device Catalogue Number: CT0010
• Device Lot Number: 19I09040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1