MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS ENT MR8 BUR; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	1847B60SCC
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: product analysis: no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in 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.
Event or Problem Description
It was reported that during cochlear implant surgery, the drilling time is extended because the burr unlocks itself when the motor is running at high speed, even though it was initially properly locked.It was reported that there was no patient impact.It was reported that the procedure was delay and procedure completed with backup product.It also states that, under these circumstances, there was a risk of injury by the surgeon during the operation.
Event or Problem Description
Handpiece was damaged and loose bearing were found.It was reported there was no patient impact.
Additional Manufacturer Narrative
H3: product analysis: product: bur entmr8 cut cbd 6mm std, lot# 0228264417: evaluation could not reproduce the reported malfunction of difficult with assembly.It was noted that no abnormalities found.Product: pss unknown motor, serial# unknown: no evaluation was performed, as the device was not returned.If the device is returned in future, product analysis may be performed h2: additional info: handpiece was damaged, it's pss unknown device, serial number and product return was requested.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.
Additional Manufacturer Narrative
H2: based on device evaluation and additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.Pli 20: handpiece was damaged, it's pss unknown device, serial number and product return was requested.But device not returned and no evaluation was not 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: ENT MR8 BUR
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23690067
• Report Number: 1625507-2025-02356
• Device Sequence Number: 10375215
• Product Code: HBE
• UDI-Device Identifier: 00763000753863
• UDI-Public: (01)00763000753863(17)290828(10)0228264417
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1847B60SCC
• Device Catalogue Number: 1847B60SCC
• Device Lot Number: 0228264417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 04/17/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/03/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female