MAUDE Adverse Event Report: PRECISION SPINE, INC HXX; SCREWDRIVER

Catalog Number 39-RD-0060

Device Problem Fracture (1260)

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

Event Date 10/09/2023

Event Type  malfunction  

Event Description

It was reported that a 4-level revision procedure for a failed fusion was performed on (b)(6) 2023, utilizing the reform pedicle screw system.All existing hardware was removed successfully, and new screw placed.Upon final tightening of the first new set screw the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken piece was removed from the set screw and the second driver in the set was used to successfully complete the procedure.There was no patient injury or significant delay to the procedure reported.

Manufacturer Narrative

H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.

Manufacturer Narrative

H3 device evaluation - the driver's tip is fractured with the fracture plane approximately at a 45-degree angle relative to the driver's longitudinal axis.This type of fracture is indicative of combination loading.It is believed that torsional loading in combination of bending moments resulted in the observed failure.It cannot be ascertained if prior loading conditions resulted in initial crack formation which culminated in the failure during this procedure.Review of device history records found (b)(4) pieces of lot 12514ts released for distribution on 3.2.2021 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 being recommended.

Event Description

It was reported that a 4-level revision procedure for a failed fusion was performed on (b)(6), 2023, utilizing the reform pedicle screw system.All existing hardware was removed successfully and new screw placed.Upon final tightening of the first new set screw the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken piece was removed from the set screw and the second driver in the set was used to successfully complete the procedure.There was no patient injury or significant delay to the procedure reported.

• Brand Name: HXX
• 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: 18074693
• MDR Text Key: 327421717
• Report Number: 3005739886-2023-00060
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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: 12514TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• 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