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

Catalog Number 37-IN-0060

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

H2 device evaluation - information provided indicates that the product will be returned for evaluation but has yet to be received.Review of device history records was not possible without lot identity.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No conclusions can be drawn.Should the product be received, a follow-up medwatch report will be filed.

Event Description

It was reported that a procedure was performed on (b)(6) 2024, utilizing the vault c acdf system.Upon attempted insertion of a screw, the self-retaining driver (37-in-0060) tip broke.The screw was only partially inserted when the tip broke, allowing removal of the screw with a pair of pliers.A second screw was readily available in the set and was successfully to complete the procedure.There was a one (1) minute delay to the procedure.

Event Description

It was reported that a procedure was performed on (b)(6) 2024, utilizing the vault c acdf system.After preparing the disc space, they used a rasp to refine the endplate.Following that, they inserted the implant into the disc and prepared the screw hole.They utilized a straight awl and then a straight drill.Upon attempted insertion of a screw, the self-retaining driver (b)(6) tip broke.The screw was only partially inserted when the tip broke, allowing removal of the screw with a pair of pliers.A second screw was readily available in the set and was inserted utilizing the fixed angle driver (b)(6).Although the screw was implanted successfully, the gears did not rotate properly when trying to insert the screw.There was no patient injury, but there was a slight delay of one (1) minute.

Manufacturer Narrative

H3 device evaluation - engineering performed a visual inspection of the complaint product.The distal tip of the t8 self-retaining driver, (b)(6), is completely fractured in a plane that is perpendicular to the shaft axis.The cause for the fracture is due to excessive torque 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 40 piece lot had been inspected and conform to drawing specifications.Complaint history review did not identify a trend for reports of this nature for this part number.The need for corrective action is not indicated at this time however, complaints will continue to be monitored.

• Brand Name: VAULT C ACDF SYSTEM
• Type of Device: 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: 18773353
• MDR Text Key: 336186796
• Report Number: 3005739886-2024-00011
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00840019916974
• UDI-Public: 00840019916974
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 37-IN-0060
• Device Lot Number: 118708MI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention