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

Model Number	HXX-39-0001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Lot number - unknown.Device availability - information provided indicates the device is available for evaluation, but at the time of this report it had not been received by the manufacturer.Occupation - other; distributor.Device manufacture date: unknown, without lot identification, manufacturing records could not be reviewed.Without the opportunity to examine the complaint product, no conclusions can be drawn regarding the root cause of the reported issue.Should the product be received, a follow-up report will be filed upon completion of investigation.
Event or Problem Description
It was reported that a posterior lumbar procedure was performed on (b)(6) 2020, utilizing the reform pedicle screw system.A 39-pa-7535 7.5 x 35 mm reform pedicle screw was implanted, subsequently the surgeon decided to reposition the screw to allow room for an si fusion.When attempting to remove the screw the tip of the reform driver with mechanical lock (hxx-39-0001) broke.A rod was immediately used to remove the screw and the procedure was successfully completed utilizing the second driver readily available in the set.There was no patient injury or significant delay to the procedure.
Event or Problem Description
It was reported that a posterior lumbar procedure was performed on (b)(6) 2020, utilizing the reform pedicle screw system.A 39-pa-7535 7.5 x 35mm reform pedicle screw was implanted, subsequently the surgeon decided to reposition the screw to allow room for an si fusion.When attempting to remove the screw the tip of a reform driver broke.A rod was immediately used to remove the screw and the procedure was successfully completed utilizing the second driver readily available in the set.There was no patient injury or significant delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver is fractured in a plane that is nomal to the driver's longitudinal axis.This failure mode is indicative of a torsional overload condition.The remaining portion of the tip is rotated slightly in the counterclockwise direction which is in agreement with torque application associated with screw removal.The cause appears to be from high torque application.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.No corrective actions are being recommended.

• 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: 10116657
• Report Number: 3005739886-2020-00017
• Device Sequence Number: 16724189
• Product Code: HXX
• UDI-Device Identifier: 00840019928809
• UDI-Public: 00840019928809
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 03/09/2023
• 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