MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC® HANDPIECE - INDIGO¿ DRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	1845000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product description: attachment (b)(4) indigo otol angled, product id: 1845020, serial #: (b)(6), udi#: (b)(4).H6: product id: 1845020, serial #: (b)(6), fdr c20, img g04130 and fdc d16 codes.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 pre-op, the handpiece heats up without accessories and load.The overheating was observed in less than 1 minute.The backup cold instruments was used to complete the procedure.The device was run at 52k rpm in standard mode.The irrigation was used during the procedure.The attachment bearing was damaged.There was no patient involvement.
Additional Manufacturer Narrative
H3:it was found in the analysis that the incoming/pre-repair temperature test was performed t ambient= 75f.After 1 minute at 60k rpm's: front= 96f, middle= 85f.After 5 minutes at 60k rpm's: front= 157f, middle= 132f and collet 197f.The connector was cracked.The motor was running rough; the bearings were worn.The collet was corroded.Based on the temperature reading, it has been determined that this event does not meet the criteria for regulatory reporting.The temperature recorded was below 118f, which is within the acceptable range and therefore not reportable.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
Additional information received that there was damaged bearing of attachment, there was no patient involvement.

• Brand Name: IPC® HANDPIECE - INDIGO¿ DRILL
• 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 ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 24411026
• Report Number: 1045254-2026-00246
• Device Sequence Number: 10605111
• Product Code: HBE
• UDI-Device Identifier: 00643169882621
• UDI-Public: (01)00643169882621(11)230720
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K081475
• 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
• Report Date (Section B): 05/05/2026

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: 1845000
• Device Catalogue Number: 1845000
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 02/22/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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: Unknown