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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event - unknown.D4 lot number - unknown.D4 primary unique device identifier number - full udi number not available without lot identification.D9 is device available for evaluation - although information provided indicates the device would be returned, to date it has not been received.H4 device manufacturing date - unknown without lot identification.H3 device evaluation - device has not been returned.Device history records and lot specific complaint history were 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.No conclusions can be drawn at this time.Should the product be returned, a follow-up report will be filed following investigation.
Event or Problem Description
It was reported that a procedure was performed on an unknown date, utilizing the reform pedicle screw system.During final tighten of a lock screw the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken piece was removed and the procedure completed successfully utilizing the second driver in the set.There was no patient injury or significant delay to the procedure.
Event or Problem Description
It was reported that a procedure was performed on an unknowndate, utilizing the reform pedicle screw system.During final tighten of a lock screw the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken piece was removed and the procedure completed successfully utilizing the second driver 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.The driver fracture is skewed relative to its longitudinal axis.This type of failure is indicative of combination loading (torsion and bending moments) but crack initiation from prior high combination loading can not be ruled out as the cause.Review of device history records found nineteen (b)(4) pieces of lot 13767ps released for distribution on 8/30/2017 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.No corrective actions are recommended at this time.

• 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: 23796381
• Report Number: 3005739886-2025-00021
• Device Sequence Number: 5571469
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: (01)00840019928366(11)170830(10)13767PS
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/18/2025

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: 13767PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2017
• 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