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

Model Number	37-IN-0060
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/04/2020
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.Initial 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 a procedure was performed in the dominican republic, on (b)(6) 2020, utilizing the vault c acdf system.After placing the first screw going upwards, the surgeon was placing the lower screw and while trying to push in, the tip of the self-retaining driver (37-in-0060) broke and stayed in the head of the screw so the screw was removed and replaced.The angled driver was used to complete the procedure.There was a delay to the procedure of twenty (20) minutes as a result.No harm to the patient was reported.The bone was only prepped with an awl, a tap was not 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.This breakage coincides with its seating location within the head of the screw.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.The surgical technique guide, lbl-stg-0016, for the vault c acdf system instructs under screw hole preparation; a.Straight awl (37-hp-0010).Using the implant as a guide, align the awl assembly within the corresponding hole on the implant and prepare the screw entry hole.B.Straight drill & drill guide (37-hp-021x & 37-hp-0030).Align the drill guide within the corresponding hole on the implant.Insert the appropriate length drill within the drill guide and prepare the hole until the drill depth stop seats on the drill guide.An optional freehand drill guide (37-hp-0015) can be used in place of the standard drill guide to control depth.C.Screw tap (37-hp-0312) align the tap within the corresponding hole and prepare the hole.Review of device history records found (b)(4) ((b)(4)) pieces of lot 49059mi were release for distribution on 6/17/2016 with no deviation or anomalies.Review of device history records did not identify a trend for reports of this nature for the reported part number.No corrective actions are being recommended since the breakage does not appear to be manufacturing related, the cause is unknown, and since the system technique guide specifies preparing the bone with drills & taps to help facilitate screw seating.
Event or Problem Description
It was reported that a procedure was performed in the dominican republic, on (b)(6) 2020, utilizing the vault c acdf system.After placing the first screw going upwards, the surgeon was placing the lower screw and while trying to push in, the tip of the self-retaining driver (37-in-0060) broke and stayed in the head of the screw so the screw was removed and replaced.The angled driver was used to complete the procedure.There was a delay to the procedure of twenty (20) minutes as a result.No harm to the patient was reported.The bone was only prepped with an awl, a tap was not used.

• 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: 9825245
• Report Number: 3005739886-2020-00011
• Device Sequence Number: 740396
• 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: 07/16/2020
• 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