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 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

H3 device evaluation - the 39-ch-0008 torque limiting handle lot 25179bm-061 that was used when the driver tip broke was returned for evaluation.Torque testing was performed by the quality engineer finding the torque release to be within design specification.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 2017 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 nineteen (b)(4) of lot 13767ps released for distribution on 8/30/2017 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 being recommended.

Event Description

It was reported that a procedure was performed on (b)(6) 2024, utilizing the reform pedicle screw system.The tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke while final tightening a lock screw.The tip was easily 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.

• 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: 18987334
• MDR Text Key: 338764399
• Report Number: 3005739886-2024-00019
• 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: 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-RD-0060
• Device Lot Number: 13767PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• 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