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	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 device evaluation - although initial information provided indicates the device would be returned for evaluation, it has not been received by the manufacturer at this time.Without the ability to examine the complaint product, no conclusions can be drawn.Review of device history records found (b)(4) pieces of lot 16565ps released for distribution on 3/13/2018 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are recommended.Should the complaint product be received, a follow-up medwatch report will be submitted upon 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.During the procedure the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken tip was retrieved, and the procedure was successfully completed utilizing the second driver readily available in the set.There was no patient injury but a slight, two-minute delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver is missing.The fracture plane is skewed relative to the driver's longitudinal axis which is indicative of failures due to combination loading (torsion and bending moments).Multiple ratchet marks are present.The cause for failure appears to be due to an overload condition associated with torque and bending moments acting upon the tip, but crack initiation from prior high loading conditions cannot be ruled out as a potential contributing factor.A counter torque wrench is included in the system and proper counter-torque wrench use would mitigate bending moments acting on the driver's tip.Review of device history records found (b)(4) pieces of lot 16565ps released for distribution on 3/13/2018 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.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 the procedure the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken tip was retrieved, and the procedure was successfully completed utilizing the second driver readily available in the set.There was no patient injury but a slight, two-minute delay to the procedure.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 250 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
• MDR Report Key: 21877509
• Report Number: 3005739886-2025-00005
• Device Sequence Number: 18084098
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: (01)00840019928366(11)180313(10)16565PS
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 16565PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2018
• 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