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	11/21/2025
Type of Reportable Event	Malfunction
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.
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.
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.
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.

• 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: 23981503
• Report Number: 3005739886-2026-00005
• Device Sequence Number: 21484226
• 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