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	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
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 while attempting to final tighten a lock screw the tip of the t25, lock-screw torque driver, reform 39-rd-0060) broke.The lock screw was removed and replaced with a new screw and tightened using the second driver readily available in the set.There was no patient injury but a five (5) minute delay to the procedure as a result of the malfunction.
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 while attempting to final tighten a lock screw the tip of the t25, lock-screw torque driver, reform 39-rd-0060) broke.The lock screw was removed and replaced with a new screw and tightened using the second driver readily available in the set.There was no patient injury but a five (5) minute delay to the procedure as a result of the malfunction.
Additional Manufacturer Narrative
H3 device evaluation - visual evaluation of the returned device by the engineer noted 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 cannot be ruled out as the cause.Review of device history records found twenty-one (21) pieces of lot 33741mm released for distribution on 6/17/2016 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: 23759157
• Report Number: 3005739886-2025-00019
• Device Sequence Number: 13284580
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: (01)00840019928366(11)250617(10)33741MM
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/13/2025

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: 33741MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2016
• 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