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	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024, utilizing the reform pedicle screw system.During the procedure, while final tightening the set screws utilizing the offset ratcheting torque handle (39-ch-0008) with the t25, lock-screw torque driver, reform (39-rd-0060) the tip of the driver broke.The broken tip was removed and the procedure was completed utilizing the second driver readily available in the set.There was no patient injury or delay to the procedure reported.
Additional Manufacturer Narrative
D4: serial number: not applicable.H3: device evaluation in process.A follow-up report will be submitted upon completion.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024, utilizing the reform pedicle screw system.During the procedure, while final tightening the set screws utilizing the offset ratcheting torque handle (39-ch-0008) with the t25, lock- screw torque driver, reform (39-rd-0060) the tip of the driver broke.The broken tip was removed and the procedure was completed utilizing the second driver readily available in the set.There was no patient injury or delay to the procedure reported.
Additional Manufacturer Narrative
H3 device evaluation - along with the t25, lock-screw torque driver, reform (39-rd-0060), an offset ratcheting torque handle, believed to be in use at the time of the tip failure was returned.Initial evaluation noted the ratcheting torque handle ratchets freely left, right and locks in the middle.It also tested below the specified torque range of 106 in/lbs +-10%, with an average reading of 85.17 in/lbs.The tip fracture on the driver is skewed at an angle relative to the driver's longitudinal axis.This type of fracture is indicative of failures due to combination loading (torsion in combination with bending moments).Multiple fracture planes are observed in the break region.It is unknown if the fracture was strictly due to loading conditions during this procedure or if crack initiation had been initiated from prior applied loading.Review of device history records for the 39-rd-0060 lot 12407ps, found a total of twenty-six (26) pieces of this lot released for distribution on 1/16/2017 (6pcs) and 2/3/2017 (20pcs) with no deviation or anomalies that would contribute 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 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 ; 6014204244
• MDR Report Key: 20641459
• Report Number: 3005739886-2024-00049
• Device Sequence Number: 12618010
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: 00840019928366
• 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): 10/14/2024

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: 12407PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2017
• 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