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

Catalog Number 39-SP-0700

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

It was reported that a revision procedure to extend an existing construct was performed on an unknown date, utilizing the reform pedicle screw system.While removing a previously implanted screw, the tip of the t20, polyaxial driver, reform degen (39-sp-0700) broke.The tip was removed and the procedure was competed utilizing other instrumentation readily available in the set.There was no patient injury or delay to the procedure.

Manufacturer Narrative

H3 device evaluation - the driver is fractured at the bottom of the hexalobe.The fracture plane is normal to the driver's longitudinal axis.This type of fracture is consistent with a failure due to torsional overload.It is unclear if the driver was fully threaded / tightened to the screw or if the driver tip was just inserted when torque was applied.Fully tightening would enable some load sharing.The part has likely seen extensive use since being fabricated in 2015 so this failure may have been initiated during prior usage.Review of device history records (ir15-1284) found thirty (30) pieces of lot 33611mm were received from the supplier, medical machining specialists, and released for distribution on 9/16/2015 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.

• 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: 18996749
• MDR Text Key: 339053312
• Report Number: 3005739886-2024-00020
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00840019928731
• UDI-Public: 00840019928731
• 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: 03/06/2024

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-SP-0700
• Device Lot Number: 33611MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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