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

Model Number	37-IN-0060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Available for evaluation - although information provided indicates the device would be returned, it has not yet been received by the manufacturer.Device manufacture date - without lot identification, date of manufacture could not be determined.Device evaluation - as the device has yet to be received by the manufacturer, no conclusions can be drawn at this time.Should the device be received, a follow-up medwatch report will be filed upon completion of investigation.
Event or Problem Description
It was reported that a procedure was performed utilizing the vault c acdf system.Upon insertion of one of the screws the self-retaining driver (37-in-0060) tip broke off.The doctor was able to remove the tip pieces and the procedure was completed successfully without injury to the patient.There was a delay of five (5) minutes because of the driver 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 partially fractured (one side of the tip) 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 25 piece lot had been inspected and conform to drawing specifications.It is noted that this lot was manufactured to revision b of the 37-in-0060 drawing, which is the outdated split tip design configuration.Root cause is excessive torque on the driver tip causing the breakage during use.The need for corrective action is not indicated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 as a design improvement was previously implemented in effort to improve tip strength however, complaints will continue to be monitored.
Event or Problem Description
It was reported that a procedure was performed utilizing the vault c acdf system.Upon insertion of one of the screws the self-retaining driver (37-in-0060) tip broke off.The doctor was able to remove the tip pieces and the procedure was completed successfully without injury to the patient.There was a delay of five (5) minutes because of the driver malfunction.

• Brand Name: VAULT C ACDF SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11872066
• Report Number: 3005739886-2021-00036
• Device Sequence Number: 3965312
• Product Code: HXX
• UDI-Device Identifier: 00840019916974
• UDI-Public: 00840019916974
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: 37-IN-0060
• Device Catalogue Number: 37-IN-0060
• Device Lot Number: 3201MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1