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	09/29/2025
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.During final torque of the surgeon used the anti-torque wrench on the screw head while tightening the lock screw in the opposite direction of the nut.At that time, the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken tip piece was removed and the procedure was completed utilizing the second lock screwdriver readily available in the set.There was a two-minute delay to the procedure but no patient injury reported.
Additional Manufacturer Narrative
D4 lot number - unknown d4 primary unique device identifier - full udi is not available without lot identification h4 device manufacture date - unknown without lot identification h3 device evaluation - without the opportunity to examine the complaint product no conclusions can be drawn.Without lot identification device history records and lot specific complaint history cannot be reviewed.Two-year complaint history review for part number only 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 upon completion of investigation.No corrective actions are recommended at this time.
Additional Manufacturer Narrative
H3 device evaluation - examination was not possible, as the product was lost during shipment to the engineer.Review of the device history records did not reveal any manufacturing deviations or anomalies, and two-year sales history did not reveal a trend for reports of this nature for this part number.The investigation could not draw any conclusions about the reported event.The need for corrective action was not indicated.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the reform pedicle screw system.During final torque of the surgeon used the anti-torque wrench on the screw head while tightening the lock screw in the opposite direction of the nut.At that time, the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken tip piece was removed and the procedure was completed utilizing the second lock screw driver readily available in the set.There was a two minute delay to the procedure but no patient injury reported.

• 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: 23981507
• Report Number: 3005739886-2026-00003
• Device Sequence Number: 18793159
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: (01)00840019928366(11)241125(10)15079TS
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 15079TS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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