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	07/16/2025
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 the patient underwent a procedure on (b)(6) 2025, utilizing the reform pedicle screw system.Subsequently a revision procedure was performed on (b)(6) 2025.To extend the existing construct.During the revision procedure it was noted that one of the ø6.5mm x 50mm reform ti modular non-cannulated - non-fluted screw (39-sg-6550) was broken mid-shaft.The broken screw was removed and replaced.It was also noted that the tip of a t25, lock-screw torque driver (39-rd-0060) broke while final tightening the last lock screw.The tip was recovered and the procedure was completed with no further issue.
Additional Manufacturer Narrative
H3 device evaluation - the lock screwdriver was visually examined.The tip is fractured with the fracture highly skewed relative to the driver's longitudinal axis.This type of fracture is typical of driver's levered on while applying torque.Multiple fracture planes are present.It is unclear if prior high loading conditions contributed to this subsequent failure.Review of device history records found a total of thirty-one (31) pieces of this lot released for distribution on 6/3/2021 (8 pcs) and 6/26/2021 (23 pcs) with no deviation or anomalies that would relate to the reported failure.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective action is recommended.
Event or Problem Description
It was reported that the patient underwent a procedure on (b)(6)2025, utilizing the reform pedicle screw system.Subsequently a revision procedure was performed on (b)(6)2025.To extend the existing construct.During the revision procedure it was noted that one of the ø6.5mm x 50mm reform ti modular non-cannulated - non-fluted screw (39-sg-6550) was broken mid-shaft.The broken screw was removed and replaced.It was also noted that the tip of a t25, lock-screw torque driver (39-rd-0060) broke while final tightening the last lock screw.The tip was recovered and the procedure was completed with no further issue.

• 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: 22778877
• Report Number: 3005739886-2025-00013
• Device Sequence Number: 15788301
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: (01)00840019928366(11)250728(10)24111TY01
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 24111TY01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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