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	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 device evaluation - both the broken shaft end and tip end were examined by eye and with the aid of a 5x loop.The fracture plane is skewed relative to the driver's longitudinal axis.This is typical of fractures due to combination loading but crack initiation from prior high loading conditions cannot be ruled out.Additional cracks are observed on the tip fragment along with a shiny planar fracture segment that appears normal to the longitudinal axis.Review of device history records found a total of thirty-one ((b)(4)) pieces of this lot released for distribution on 6/3/2021 ((b)(4)) and 6/26/2021 ((b)(4)) with no deviation or anomalies that would relate to the reported failure.Two-year complaint history review did not identify a trend for reports of this nature for this part number.No corrective actions are recommended.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the reform pedicle screw system.While final tightening a lock screw, the t25, lock-screw torque driver, reform (39-rd-0060) tip broke off.The broken tip was removed with a pituitary and the procedure was complete utilizing the second driver readily available in the set.There was no patient injury or delay the procedure.

• 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: 22851835
• Report Number: 3005739886-2025-00016
• Device Sequence Number: 14557734
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: (01)00840019928366(11)030621(10)24111TY01
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: 24111TY01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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