MAUDE Adverse Event Report: LIFE SPINE ARX SAI; DRIVER

Model Number	175-147
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The drive tip broke in the screw and quickly was retrieved and caused no surgical delays or effects on patients.The surgeon had bottom out the screw and had kept torquing the screw driver, the driver was stuck between the tulip of the screw and patient bone with the additional torque caused undue stress on the driver tip.
Event or Problem Description
It was stated that "the instruments broke with normal use.One driver locked on the t-handle while implanting a screw and the other driver tip broke while implanting a screw.They were implanting the first sai screw when the t-handle seized up on the driver after the screw bottomed out and they couldn't get it off.The second driver was then used to implant a second sai screw and as it bottomed out, the tip of the driver broke off.They were able to retrieve the piece.".

• Brand Name: ARX SAI
• Common Device Name: DRIVER
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22030161
• Report Number: 3004499989-2025-00007
• Device Sequence Number: 15481902
• Product Code: NKB
• UDI-Device Identifier: 00190837073671
• UDI-Public: (01)00190837073671(10)CNW24111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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
• Device Lot Number: CNW24111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown