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

Catalog Number	37-IN-0060
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation - other; distributor.Device evaluation - information provided indicates that the product will be returned.To date it has not been received by the manufacturer.Once received and evaluation is complete a follow-up medwatch report will be submitted.Review of device history record found seventy-one (71) pieces of lot 49059mi were released for distribution on (b)(6) 2016 with no deviation or anomalies.Complaint history review did not identify a trend for reports of this nature for this part number.
Event or Problem Description
It was reported that a procedure was performed in the (b)(6),on (b)(6) 2019, utilizing the vault c acdf system.After placing the first screw, the surgeon was placing the lower screw and while trying to push the screw in, the tip broke and was left in the screw.The broken tip piece was able to be removed but resulted to a delay to the procedure of thrity (30) minutes.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2019, in the dominican republic, utilizing the vault c acdf system.After placing the first screw the surgeon was placing the lower screw and while trying to push the screw in, the tip broke and was left in the screw.The broken tip piece was able to be removed and the screw was removed and replaced, resulting in a delay to the procedure of thirty (30) minutes.
Additional Manufacturer Narrative
H3 product evaluation - the tip of the driver was examined by eye and with the aid of a 5x loop.The fracture plane is skewed relative to the driver's longitudinal axis with this plane area representing more than 75% of the fracture surface.The drive feature of the screw was also examined with the aid of the 5x loop.Signs of considerable wear damage are present around the screw's drive feature.It is unclear if the observed wear was a result of issues during implantation or if they are a result of issues with explantation.It could not be ascertained if the failure was a result of prior loading conditions that initiated a crack that had progressed and subsequently resulted in the observed failure or if torsion coupled with levering while tightening or levering while inserting the screw resulted in the observed condition.It was also noted that the screw broke while being pushed in.It is unclear as to what was actually occurring since the screw is to be threaded into a hole that is drilled and tapped to mitigate high torsional loads.If it broke while being pushed in it may be construed that there was an issue trying to get the screw placed in the operative site due to the exposure of the operative cavity.Review of device history record found seventy-one (71) pieces of lot 49059mi were released for distribution on 6/17/2016 with no deviation or anomalies.Complaint history review back to the date of manufacture did not identify a trend for reports of this nature.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: 9341540
• Report Number: 3005739886-2019-00049
• Device Sequence Number: 428597
• 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

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 Catalogue Number: 37-IN-0060
• Device Lot Number: 49059MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1