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

Model Number	37-IN-0060
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: unknown.Although there was no patient injury or significant delay to the procedure, this event is being reported as an adverse event / serious injury due to medical intervention required to remove and replaced the screw following driver tip failure.Reporter occupation: other; distributor.Information received indicates that the device will be returned for evaluation, but has not yet been received.Upon receipt and completion of evaluation, a follow-up medwatch report will be filed.
Event or Problem Description
It was reported that during a procedure performed on or around (b)(6) 2020, in (b)(6), the tip of the self-retaining driver (37-in-0060) broke when the screw was approximately 2/3rds of the way seated.The broken tip remained in the screw, which was subsequently removed from the patient and a new screw inserted utilizing the angled driver which was readily available in the set.There was no patient issues reported but, there was a delay to the procedure of approximately 30 minutes as a result.It was noted that the bone was prepped only with an awl prior to attempted screw insertion, no tap was used.
Event or Problem Description
It was reported that during a procedure performed on or around (b)(6) 2020, in the dominican republic, the tip of the self-retaining driver (37-in-0060) broke when the screw was approximately 2/3rds of the way seated.The broken tip remained in the screw, which was subsequently removed from the patient and a new screw inserted utilizing the angled driver which was readily available in the set.There was no patient issues reported but, there was a delay to the procedure of approximately 30 minutes as a result.It was noted that the bone was prepped only with an awl prior to attempted screw insertion, no tap was used.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver was examined by eye and with the aid of a 5x loop.The driver's tip is completely fractured in a plane that is perpendicular to its longitudinal axis.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.It was noted that the screw was seated 2/3 of the way when the failure occurred and that only an awl was used to prepare the bone.System drills and taps are available and recommended per the surgical technique guide to facilitate screw seating, surgical exposure may also impact the forces applied to the driver.Review of device history records found seventy-one (71) pieces of lot 49059mi were released for distribution on (b)(6) 2016 with no deviation or anomalies.Review of complaint history did not identify a trend for reports of this nature for this part number.No corrective actions are being recommended.

• 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: 9825409
• Report Number: 3005739886-2020-00012
• Device Sequence Number: 19017723
• Product Code: HXX
• UDI-Device Identifier: 00840019916974
• UDI-Public: 00840019916974
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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): 02/18/2020

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-IN-0060
• Device Catalogue Number: 37-IN-0060
• Device Lot Number: 49059MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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: Required Intervention