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.H3: device evaluation: initial information indicates that the product is available for evaluation but has yet to be returned to the manufacturer.Review of device history records found fifty-two (52) pieces of lot: 12877ts released for distribution on 7/12/2021 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.Without the ability to examine the complaint product, no conclusions can be drawn.Should the product be received, a follow-up medwatch report will be filed.
Event or Problem Description
It was reported that a revision procedure was performed on an unknown date, utilizing the reform pedicle screw system.During attempted removal of a previously torqued lock screw, the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The tip was retrieved and discarded, and the procedure was completed utilizing other instrumentation readily available.There was no patient injury or delay to the procedure reported.Reason for need for revision is unknown at this time.
Additional Manufacturer Narrative
H3 device evaluation - the drivers tip is missing.The fracture plane is irregular and skewed relative to the drivers longitudinal axis.This type of fracture is indicative of off axis loading.Multiple fracture planes are present.Crack initiation from prior high torque high bending moments may have been a contributing factor for this failure.No corrective actions are being recommended.
Event or Problem Description
It was reported that a revision procedure was performed on an unknown date, utilizing the reform pedicle screw system.During attempted removal of a previously torqued lock screw, the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The tip was retrieved and discarded, and the procedure was completed utilizing other instrumentation readily available.There was no patient injury or delay to the procedure reported.Reason for need for revision is unknown 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: 22481113
• Report Number: 3005739886-2025-00011
• Device Sequence Number: 15439412
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: (01)00840019928366(11)21207(10)12877TS
• 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): 06/16/2025

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: 12877TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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