MAUDE Adverse Event Report: PRECISION SPINE, INC VAULT C ACDF SYSTEM; SCREWDRIVER

Model Number	37-IN-0060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 device evaluation - although information indicates that the product will be returned, it has not been received by the manufacturer.Without the opportunity to examine the device no conclusions can be drawn.Review of device history records found 22 pieces of lot 00672pt released for distribution on (b)(6) 2025 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.No corrective action is required.Should the product be received a follow-up report will be filed.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the vault c acdf system.During the placement of the superior screw, an awl was used to initiate the screw trajectory.A screwdriver with a size 14 screw was then used.At this point, the tip of the self-retaining driver (37-in-0060) broke.The fractured tip was successfully removed from the screw.A second screwdriver was then used, allowing for the proper placement of both the superior and inferior screws, both size 14.There was a two-minute delay to the procedure but no injury to the patient as a result of the malfunction.
Additional Manufacturer Narrative
H3 device evaluation - engineering performed a visual inspection of the complaint product.The distal tip of the t8 self-retaining driver, 37-in-0060, is fractured in a plane that is mainly perpendicular to the shaft axis.The cause for the fracture may be due to combined torsional and bending moment loading conditions experienced during this procedure or due to this and prior high loading conditions that may have results in cracks and manifested itself in this failure.The device history record confirms that the 22 piece lot had been inspected and conform to drawing specifications.Root cause is excessive torque on the driver tip causing the breakage during use.The need for corrective action is not indicated at this time however, complaints will continued to be monitored.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the vault c acdf system.During the placement of the superior screw, an awl was used to initiate the screw trajectory.A screwdriver with a size 14 screw was then used.At this point, the tip of the self-retaining driver (37-in-0060) broke.The fractured tip was successfully removed from the screw.A second screwdriver was then used, allowing for the proper placement of both the superior and inferior screws, both size 14.There was a two-minute delay to the procedure but no injury to the patient as a result of the malfunction.

• Brand Name: VAULT C ACDF SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 24028937
• Report Number: 3005739886-2026-00006
• Device Sequence Number: 8887578
• Product Code: HXX
• UDI-Device Identifier: 00840019916974
• UDI-Public: (01)00840019916974(11)250227(10)00672PT
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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
• Device Model Number: 37-IN-0060
• Device Catalogue Number: 37-IN-0060
• Device Lot Number: 00672PT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown