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

Model Number	39-RD-0060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the reform pedicle screw system.Upon final tightening of the lock screws, the tip of two of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken tips were removed and the procedure was completed utilizing another driver readily available.There was a five (5) minute delay to the procedure but no patient injury.
Additional Manufacturer Narrative
D4 lot number - unknown.D4 primary unique device identifier - complete udi number not available without lot identification.D9 is this device available for evaluation - information provided indicates that the device is available for return but has not been received by the manufacturer at this time.H3 - review of device history records and lot specific complaint history is not possible without lot identification.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.Should the product be received, a follow-up report will be filed following completion of investigation.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the reform pedicle screw system.Upon final tightening of the lock screws, the tip of two of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken tips were removed and the procedure was completed utilizing another driver readily avialable.There was a five (5) minute delay to the procedure but no patient injury.
Additional Manufacturer Narrative
H3 device evaluation - the driver exhibits fractured surfaces that are skewed relative to the driver's longitudinal axis.This type of failure is indicative of combination loading (torque and bending moments).Crack initiation may have been initiated at a prior usage point where high combination loads were applied.Review of device history records found (b)(4) pieces of this released for distribution on 11/6/2023 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 23936895
• Report Number: 3005739886-2025-00024
• Device Sequence Number: 9448235
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: (01)00840019928366(11)231106(10)01008UP
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 39-RD-0060
• Device Catalogue Number: 39-RD-0060
• Device Lot Number: 01008UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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