MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM POLYAXIAL DRIVER; SCREWDRIVER

Catalog Number	39-SP-0700
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Occupation - distributor.Product evaluation - the fracture surface was examined with the aid of a 5x loop.The fracture area includes two distinct areas.A shiny surface is exhibited around a portion of the periphery and a dull grey area is present else were.It is believed that the shiny area is representative of an area of initial crack propagation.Crack initiation and progression would have occurred in prior high force use.The grey is representative of the area that subsequently failed during this procedure.The reduced cross sectional area due to prior crack initiation would result in less force required to complete part failure.Review of device history records found a total of (b)(4) pieces of lot 3267mm-r were released for distribution in april of 2015 with no deviation or anomalies that would relate to the reported issue.No corrective actions are being proposed as a design more resistant to breakage has been released.
Event or Problem Description
It was reported that a 2-level plif procedure was performed by on (b)(6) 2019, utilizing the reform pedicle screw system.Upon implantation of a reform pedicle screw the tip of the reform polyaxial driver (39-sp-0700) broke.The tip was removed and the procedure was completed utilizing another driver readily available in the set.There was no significant delay to the procedure or patient injury as a result of the malfunction.

• Brand Name: REFORM POLYAXIAL DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 9235121
• Report Number: 3005739886-2019-00046
• Device Sequence Number: 1696018
• Product Code: HXX
• UDI-Device Identifier: 00840019928731
• UDI-Public: 00840019928731
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 39-SP-0700
• Device Lot Number: 7367MM-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1