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	05/19/2025
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 during procedure performed on (b)(6), 2025, the tip of a t25, lock-screw torque driver, reform (39-rd-0060) broke when final tightening a lock screw.The tip was removed and the procedure was completed utilizing the second lock-screw torque driver, reform (39-rd-0060) and a t25 driver, persuader, long (c3492) that were readily available.There was no patient injury or surgical delay reported.
Event or Problem Description
It was reported that during procedure performed on (b)(6) 2025, the tip of a t25, lock-screw torque driver, reform (39-rd-0060) broke when final tightening a lock screw.The tip was removed and the procedure was completed utilizing the second lock- screw torque driver, reform (39-rd-0060) and a t25 driver, persuader, long (c3492) that were readily available.There was no patient injury or surgical delay reported.
Additional Manufacturer Narrative
H3 device evaluation - evaluation upon receipt of the device found that the tip is not broken, but twisted.The tip of the driver is present but is slightly deformed (twisted).It can not be ascertained if the part had sustained damage from prior high loading conditions.The suspected cause for the observed deformation is high torque application.Review of device history records found twenty-eight (28) pieces of this lot released for distribution on 6/12/2023 with no deviation or anomalies.Two-year complaint history review did not identify a trend for reports of this nature for the reported part number.No corrective actions are recommended.

• 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
• MDR Report Key: 22211646
• Report Number: 3005739886-2025-00009
• Device Sequence Number: 8602030
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: (01)00840019928366(11)230612(10)00978UP
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 05/21/2025

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: 00978UP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/23/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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