MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC RIALTO¿ SI FUSION SYSTEM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M

Model Number	7426000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis # (b)(4): part # 7426000, lot # em16h001 visual inspection confirmed the entire torx tip of instrument has been sheared off.Optical examination of the fracture surface revealed a fairly flat fracture surface with circular material flow.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.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a medtronic representative regarding a drivers used in a fusion.It was reported that while inserting rialto screw into the patient, it was understood that there were already two other screws in the patient, so this new third screw was up against the previous screws and the surgeon wanted to make sure he drove the implant in all the way which ended up twisting the tip of the driver and broke the tip.Broken tip of screwdriver remained inside the screw in the patient, was unable to remove.Pre-operative diagnosis for this procedure found out to be previously failed si fusion.No adverse event occurred to patient.There were no further complications that were reported.Additional information received that the non navigated instrument tip was left inside the patient, inside the implant.The nav tip was twisted, not snapped.The given revision surgery was not performed as a result of use of medtronic products.No additional surgery needed to remove the broken tip inside the patient.

• Brand Name: RIALTO¿ SI FUSION SYSTEM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M
• 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: 21293403
• Report Number: 1030489-2025-00546
• Device Sequence Number: 18038868
• Product Code: HWE
• UDI-Device Identifier: 00643169572546
• UDI-Public: 00643169572546
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2025

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: 7426000
• Device Catalogue Number: 7426000
• Device Lot Number: EM16H001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female