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

Model Number	37-IN-0060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: unknown.Occupation: other; sales representative.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that a one level acdf case was performed on (b)(6) 2020, utilizing the vault c acdf interbody system.The doctor was trying to reposition and adjust the depth of the screw when the tip of the self-retaining driver (37-in-0060) broke in the head of the screw.The tip was able to be removed with a hemostat and the procedure was completed utilizing the second driver readily available in the set.There was a delay of approximately 7-8 minutes with no patient injury.
Event or Problem Description
It was reported that a one level acdf case was performed on (b)(6) 2020, utilizing the vault c acdf interbody system.The doctor was trying to reposition and adjust the depth of the screw when the tip of the self-retaining driver (37-in-0060) broke in the head of the screw.The tip was able to be removed with a hemostat and the procedure was completed utilizing the second driver readily available in the set.There was a delay of approximately 7-8 minutes with no patient injury.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver was examined by eye and with the aid of a 5x loop.The design configuration that broke was of the older split tip design that was subsequently replaced by a solid design.The cause for the breakage was noted as a side load being applied to the screw while also adjusting the screw height.Levering on the screw with the driver in an effort to reorient the screw while applying torque can result in loading conditions that can lead to device failure.The part that broke had been manufactured over 5 years ago and may have also been subjected to prior high loading conditions that subsequently manifested itself in this fracture.Review of device history records found thirty-one pieces of lot 3200mm were released for distribution on 6/6/2014 with no deviation or anomalies.No corrective actions are being recommended since the failure does not appear to be attributed to part fabrication issues with the part available for use for more than 5 years, and since high combined loading conditions may result in these types of failures.

• 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: 9687686
• Report Number: 3005739886-2020-00005
• Device Sequence Number: 14147777
• Product Code: HXX
• UDI-Device Identifier: 00840019916974
• UDI-Public: 00840019916974
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: 3200MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1