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

Model Number	37-HP-0400
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: other; distributor.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2015-00038 / 00039).
Event or Problem Description
During acdf surgery performed in (b)(6) on (b)(6) 2020, the surgeon was using the angled screw driver (37-hp-0400 lot 0143it-r) to insert the screw as the angle was difficult to use the straight driver.While he was using the angled driver a sound popped from the driver and it stopped rotating smoothly.A second fixed angle driver (37-hp-0400 lot 0056itr) was attempted to be used but it was not holding the screw, as he was trying to insert the screw in the hole it was detaching from the screw driver.Bone wax was attempted to be used on the tip but was unsuccessful.There was no injury to the patient but a 1-1/2 hour delay to the procedure as a result of the reported issues.
Additional Manufacturer Narrative
H3 device evaluation - engineering performed a visual inspection of the complaint product.The distal tip of the driver shaft assembly, 37-hp-0402, and the drill tip gear, 37-hp-0411 have no visible damage.Engineering was unable to reproduce the reported failure.A potential root cause is that during instrument assembly in the field, the driver shaft assembly was not fully seated into the outer body sleeve, 37-hp-0407.This would cause a misalignment of the gear features between the shaft and tip that could explain the driver not rotating smoothly.However, this cannot be confirmed and therefore, a root cause could not be determined.Review of device history records found a total of fifteen (15) pieces of lot 0143it-r were released for distribution with no deviation or anomalies.Complaint history review did not identify a trend for reports of this nature for this part number.As a definite root cause could not be identified and there was not a trend for reports of this nature identified, the need for corrective action is not indicated.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2015-00039-1).
Event or Problem Description
During acdf surgery performed in dubai, uae on (b)(6) 2020, the surgeon was using the angled screw driver (37-hp-0400 lot 0143it-r) to insert the screw as the angle was difficult to use the straight driver.While he was using the angled driver a sound popped from the driver and it stopped rotating smoothly.A second fixed angle driver (37-hp-0400 lot 0056itr) was attempted to be used but it was not holding the screw, as he was trying to insert the screw in the hole it was detaching from the screw driver.Bone wax was attempted to be used on the tip but was unsuccessful.There was no injury to the patient but a 1-1/2 hour delay to the procedure as a result of the reported issues.

• 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: 10938825
• Report Number: 3005739886-2020-00038
• Device Sequence Number: 13592816
• Product Code: HXX
• UDI-Device Identifier: 00840019917100
• UDI-Public: 00840019917100
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 37-HP-0400
• Device Catalogue Number: 37-HP-0400
• Device Lot Number: 0143IT-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization