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	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis could not confirmed the reported fault.No faults found.H6: imdrf annex codes c19, d14 are applicable for this product continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 1845020, serial/lot #: (b)(6), udi#: (b)(4) ; h3: analysis could not confirmed the reported fault.However, the angled attachment found to be corroded inside the base, the locking mechanism not working properly.Not locking burr in securely, it's found to be noisy.H6: imdrf annex codes c0601, d02 are applicable for this product id: 1845010, serial/lot #: (b)(6), udi#: (b)(4).H3: analysis could not confirmed the reported fault.No faults found.H6: imdrf annex codes c19, d14 are applicable for this product 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 indigo drill and attachments very hot when used.There was no patient involvement.
Additional Manufacturer Narrative
H3: the pre-repair temperature test results were t1: 81.5degf t2: 83.4degf.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 1845020, serial/lot #: (b)(6), ubd:, udi#: (b)(4); h3: analysis was not able to perform pre-repair temperature tests due to faulty locking mechanism.Product id: 1845010, serial/lot #: (b)(6), ubd: , udi#: (b)(4).H3: pre-repair temperature test results for 1 minute are 83.2 f at distal and 82.4 f at base which are with in limits.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: 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: 22936143
• Report Number: 1045254-2025-02082
• Device Sequence Number: 18611707
• Product Code: HBE
• UDI-Device Identifier: 00613994933713
• UDI-Public: (01)00613994933713(17)501231
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/21/2025

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: 1845000
• Device Catalogue Number: 1845000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Sex: Unknown