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	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 - device evaluation in process.A follow-up report will be submitted upon completion.
Event or Problem Description
It was reported that a revision procedure was performed on (b)(6) 2024, utilizing the reform pedicle screw system, to extend an existing construct from a competitor.While attempting to remove the competitor's existing hardware, the tip of the lock-screw torque driver (39-rd-0060) broke.The screw was "helicoptered" out and the procedure was completed successfully.
Event or Problem Description
It was reported that a revision procedure was performed on (b)(6) 2024, utilizing the reform pedicle screw system, to extend an existing construct from a competitor.While attempting to remove the competitor's existing hardware, the tip of the lock-screw torque driver (39-rd-0060) broke.The screw was "helicoptered" out and the procedure was completed successfully.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver was examined by eye and with the aid of a loop.The fracture plane is skewed relative to the driver's longitudinal axis and multiple fracture planes exist.This type of fracture is indicative of failures due to combination loading.The application of high toque in combination with bending moments are suspected to be the cause for the failure but usage with a competitive design and damage from prior high force application cannot be ruled out as potential contributing factors.It is not believed that the counter torque wrench was used during the explantation of the competitive device.Proper use of a counter torque wrench would mitigate bending moment application.Review of device history records found thirty-three (33) pieces of lot 00351pt released for distribution on 5/15/2022 with no deviation or anomalies.Two-year complaint history review did not reveal 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 ; 6014204244
• MDR Report Key: 19838629
• Report Number: 3005739886-2024-00043
• Device Sequence Number: 15395934
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 00351PT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2022
• 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