MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® BALLAST¿ SPINAL SYSTEM; SCREWDRIVER

Model Number	25100401
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for unknown indication.It was reported that the screws were cold welded/stripped due to driver malfunction intraoperatively.Had to helicopter out after numerous attempts to remove using a multitude of drivers.One of the driver was severely warped after attempting to place 10.5 screw.When attempting to place second screw (10.5x80) the torx tip of the driver snapped off and lodged inside the tulip/torx interface of the screw.Fragments could not be removed and it was left in the pt.The other driver was severely warped after attempting to place 9.5 screw.Surgeon was fearful of snapping off tip of the driver again so the decision was made to helicopter the screw out and leave unilateral pelvic fixation.Additional information received from manufacturer representative that the procedure involved was psf l2-pelvis with tlif l3-5.Pre-op diagnosis m43.16/m54.16/m40.30/m47.26.Both ballast drivers were severely warped and stripped.The product was used in surgery on the patient.Products will be returned.There were no patient symptoms or complications reported as a result of this event.
Additional Manufacturer Narrative
H3: product analysis: (b)(4) lot# ct15l086 visual and optical inspection revealed the entire torx tip has been sheared off consistent with interface during usage.Optical examination of the fracture surface at the base of the driver tip identified a fairly flat fracture surface and circular material displacement.This type of damage is consistent with torsional overload.This regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CD HORIZON® BALLAST¿ SPINAL SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21444744
• Report Number: 1030489-2025-00964
• Device Sequence Number: 12731238
• Product Code: HXX
• UDI-Device Identifier: 00643169623996
• UDI-Public: 00643169623996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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 Model Number: 25100401
• Device Catalogue Number: 25100401
• Device Lot Number: CT15L086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Unknown