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 02/17/2024

Event Type  Injury  

Event Description

It was reported that a procedure was performed in the dominican republic 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.While attempting to insert a screw, the tip of the self-retaining driver (37-in-0060) broke.The tip was unable to be removed from the head of the screw so the screw was removed and replaced utilizing the angled driver readily available in the set.There was a one (1) minute delay to the procedure due to the malfunction.No patient injury was reported.

Manufacturer Narrative

Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.

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.Two year complaint history review did not reveal 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.

Event Description

It was reported that a procedure was performed in the dominican republic 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.While attempting to insert a screw, the tip of the self-retaining driver (b)(6) broke.The tip was unable to be removed from the head of the screw so the screw was removed and replaced utilizing the angled driver readily available in the set.There was a one (1) minute delay to the procedure due to the malfunction.No patient injury was reported.

• 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: 19060840
• MDR Text Key: 339608188
• Report Number: 3005739886-2024-00022
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• 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: 49059MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• 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