MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SOLERA 5.5/6.0; SCREWDRIVER

Model Number	5584009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E: first name and last name of initial reporter is unknown.H3: product analysis of part# 5584009, lot# fa13c001 visual and optical examination confirmed approximately 2mm of instrument tip has been stripped and deformed, consistent with interface during usage.The remaining torx tip has been twisted.This type of damage is consistent with torsional overload.H11: 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.
Event or Problem Description
Information was received from a healthcare facility via a medtronic representative regarding a driver to be used on a patient in an l3-l5 posterior lumbar fusion with reduction screws for an unknown spinal indication.It was reported that when preparing for surgery, the rep noticed that the rmas break off driver tip was broken.They removed the driver off the field before surgery began and inspected the driver post-op to determine that the tip of the driver was broken.There were no patient symptoms or complications as a result of this event.No further complications were reported/ anticipated.Additional information was received.It was reported that the product was not used on the patient.

• Brand Name: CD HORIZON SOLERA 5.5/6.0
• 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: 21289839
• Report Number: 1030489-2025-00527
• Device Sequence Number: 9355470
• Product Code: HXX
• UDI-Device Identifier: 00643169064157
• UDI-Public: 00643169064157
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2025

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: Other
• Device Model Number: 5584009
• Device Catalogue Number: 5584009
• Device Lot Number: FA13C001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female