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

Catalog Number 39-RD-0060

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

H3 device evaluation - the driver was returned with a fracture of the tip.The fracture plane is skewed relative to the driver's longitudinal axis.This is indicative of parts failing under combination loading.It is believed that bending moments were applied in combination with torque which led to this failure.The part has likely seen extensive use since being fabricated in 2014 so this failure may have been initiated during prior usage.It is unclear if a counter torque wrench was being used during set screw tightening.Proper use of a counter torque wrench helps mitigate bending moments acting on the driver's tip.Review of device history records found ten (10) pieces of lot 0127it released for distribution on (b)(6) 2014 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 at this time.

Event Description

It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform pedicle screw system.While final tightening the last lock screw the torque limiting handle torqued out after the initial two clicks, so the surgeon gave it some extra turns resulting in the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken piece was recovered, and the case was completed utilizing other instrumentation readily available in the set.There was no patient injury or delay to the procedure.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Type of Device: 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: 18625851
• MDR Text Key: 334347443
• Report Number: 3005739886-2024-00007
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: 00840019928366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 39-RD-0060
• Device Lot Number: 0127IT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1