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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
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 back pain at t5-t12.It was reported that the driver was stripped when trying to remove screws from patient under power.The rialto driver was broken at the tip and the tip was recovered from the patient.The retrieved tips of drivers were discarded at the facility.There were no fragments left inside patient body.The event was happened during a revision case, patient required a laminectomy at t8 <(>&<)> t9.There was no allegation against the implanted hardware related to the case.The surgeon removed and replaced rods to gain access for a laminectomy.Procedure was t5-t10 hardware revision.There were no patient symptoms reported, no additional treatment or surgery performed.No further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis of 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 and 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.

• 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: 21343340
• Report Number: 1030489-2025-00667
• Device Sequence Number: 7835998
• Product Code: HWE
• UDI-Device Identifier: 00643169572546
• UDI-Public: 00643169572546
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/10/2025

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: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 02/10/2025
• 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 Age: 81 YR
• Patient Sex: Female