MAUDE Adverse Event Report: MEDTRONIC XOMED INC. MIDAS REX MR8; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	MR8-SP14MH30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the procedure of posterior spinal fusion device shaft broke upon startup.No patient impact reported.The procedure was completed with the backup product.No additional intervention was performed or planned as a result of this event.It was reported that the procedure was completed with backup product.Upon follow up it was confirmed that there was no patient impact.
Additional Manufacturer Narrative
H3: product analysis for mr8-sp14mh30 with lot #0230374828: no conclusion can be drawn.No evaluation was performed as the product was reported to have been discarded.Therefore, returned device analysis was not able to be performed.If the device is returned in the future, product analysis may be performed.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: MIDAS REX MR8
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21685289
• Report Number: 1045254-2025-00960
• Device Sequence Number: 18355310
• Product Code: HBE
• UDI-Device Identifier: 00763000514006
• UDI-Public: 00763000514006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: MR8-SP14MH30
• Device Catalogue Number: MR8-SP14MH30
• Device Lot Number: 0230374828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2024
• 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: 78 YR
• Patient Sex: Male