MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM PEDICLE SCREW SYSTEM; SCREWDRIVER

Model Number	HXX-39-0001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter occupation; sales representative.Device evaluation - the driver was reviewed by eye and with the aid of a 5x loop.The tip of the driver is sheared off along with the "t" feature that is welded to the drive shaft.The hexalobe driver feature fracture plane is normal to the driver's longitudinal axis.It is believed that the fracture may have been initiated in prior usage over the products 7-year field life.Review of device history records found thirteen (13) pieces of lot 00069up released for distribution on 8/18/2015 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.Corrective actions are not recommended at this time.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, utilizing the reform pedicle screw system.During attempted screw insertion the tip of the reform driver with mechanical lock (hxx-39-0001) broke.The tip was removed from the head of the screw and the procedure was completed utilizing the second driver readily available in the set.There was a 5-10 minute delay to the procedure from removing the broken tip.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 14567948
• Report Number: 3005739886-2022-00016
• Device Sequence Number: 4728262
• Product Code: HXX
• UDI-Device Identifier: 00840019928809
• UDI-Public: 00840019928809
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/10/2022

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 Model Number: HXX-39-0001
• Device Catalogue Number: HXX-39-0001
• Device Lot Number: 00069UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown