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

Model Number 37-HP-0400

Device Problems Device Slipped (1584); Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

Patient information - unknown.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 2 of 2 mdrs filed for the same event reference 3005739886-2015-00038.

Event 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.

Manufacturer Narrative

H2 device evaluation: engineering performed a visual inspection of the complaint product.There is no visible damage or deformity of the driver tip.Engineering was unable to reproduce the reported failure with mating parts.Instrument was inspected upon return from the field and no issues were found.Review of device history records found twenty-two (22) pieces were released for distribution with no deviation or anomalies.Complaint history review did not reveal 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 2 of 2 mdrs filed for the same event (reference 3005739886-2015-00038-1/00039-1).

Event 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
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 10938927
• MDR Text Key: 219327073
• Report Number: 3005739886-2020-00039
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00840019917100
• UDI-Public: 00840019917100
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37-HP-0400
• Device Catalogue Number: 37-HP-0400
• Device Lot Number: 0056IT-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization