MAUDE Adverse Event Report: LIFE SPINE, INC. ARX® SPINAL FIXATION SYSTEM; SCREWDRIVER

Model Number	175-147
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that, "the cannulated driver tip sheared off within the hexalobe of the bone screw when dr.Clark was trying to bury the arx ø10.5mm sai screw into the ilium.The screw with the fractured drivertip was then removed from the patient with all components retrieved from the patient.".
Additional Manufacturer Narrative
The device was not returned at this time so the reported event could not be confirmed or fully evaluated.Based on the description of the event, it is hypothesized that the root cause of the reported device failure was insufficient mechanical properties at the distal tip of the screwdriver to withstand the torsional loads applied during use.When the tulip head is fully seated against the patient bone, continued torque application would likely result in either stripping the screw or fracturing the driver.Given the deep thread design of the bone screws, which makes them resistant to stripping, the reported failure occurred at the driver's tip.

• Brand Name: ARX® SPINAL FIXATION SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22310477
• Report Number: 3004499989-2025-00012
• Device Sequence Number: 12761873
• Product Code: NKB
• UDI-Device Identifier: 00190837073671
• UDI-Public: (01)00190837073671
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: 175-147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female