MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM PEDICLE SCREW SYSTEM; SCREWDRIVER

Catalog Number	39-RD-0060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
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 lock screws, the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke while using a counter torque wrench.The broken tip was removed and the procedure completed utilizing the second driver readily available in the set.There was no patient injury or delay to the procedure.
Additional Manufacturer Narrative
H3 - device evaluation in process.A follow-up report will be submitted upon completion.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver was broken off.The fracture plane is skewed relative to the driver's longitudinal axis which is indicative of a failure due to combination loading.It is believed that bending moments in combination with torsional loading ultimately resulted in this failure.Crack initiation may have resulted from prior torsional and bending moment loading which manifested in this subsequent failure.The use of a counter torque wrench was noted which when used properly mitigates bending moments acting on the tip.Review of device history records found fifteen (15) pieces of lot 00945up released for distribution on 4/29/2022 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are recommended at this time.
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 lock screws, the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke while using a counter torque wrench.The broken tip was removed and the procedure completed utilizing the second driver readily available in the set.There was no patient injury or delay to the procedure.

• 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: 19633103
• Report Number: 3005739886-2024-00033
• Device Sequence Number: 7137604
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: 00840019928366
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/04/2024

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 Catalogue Number: 39-RD-0060
• Device Lot Number: 00945UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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