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	08/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other; distributor.Device evaluation - information provided indicates that the product will be returned for evaluation, it has not yet been received by the manufacturer.Upon receipt, and completion of investigation, a follow-up medwatch will be submitted.
Event or Problem Description
It was reported that during acdf surgery on (b)(6) 2020, performed in (b)(6), the surgeon was using the self-retaining driver (37-in-0060) to insert the screw when the tip of the screw driver broke inside the body of the patient and the screw fell from the screw driver.The surgeon was able to remove the broken tip and use the second driver in the set to insert the screw.The procedure was successfully completed with no patient injury but a 30 minute delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - engineering performed a visual inspection of the complaint product.The split tip of the t8 driver is completely fractured on one side of the instrument.The device history record, confirms that the 10 piece lot had been inspected and conform to drawing specifications.It is noted in this complaint that this t8 split tip driver has been in use for approximately one year.The cause for the fracture is unknown but 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.However, this cannot be confirmed and therefore, a root cause could not be determined.Review of device history records found ten (10) pieces of lot 3191mm were released for distribution on 3/18/2014 with no deviation or anomalies.Two-year complaint history (10.20.2018-10.20.2020) review found this to be the only report of this nature for the reported lot.As a definite root cause could not be identified the need for corrective action is not indicated.
Event or Problem Description
It was reported that during acdf surgery on (b)(6) 2020, performed in dubai, the surgeon was using the self-retaining driver (37-in-0060) to insert the screw when the tip of the screw driver broke inside the body of the patient and the screw fell from the screw driver.The surgeon was able to remove the broken tip and use the second driver in the set to insert the screw.The procedure was successfully completed with no patient injury but a 30 minute delay to the procedure.

• 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: 10829938
• Report Number: 3005739886-2020-00034
• Device Sequence Number: 2829413
• Product Code: HXX
• UDI-Device Identifier: 00840019916974
• UDI-Public: 00840019916974
• 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): 10/19/2020

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: 3191MM
• 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: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/12/2020
• 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