MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC® FOOTPEDAL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I

Model Number	1898430
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: analysis did not find any fault with this device.Concomitant medical products: analysis did not find any fault with this device 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 brainsurgery, when drilling in the skull bone, items did not stop drilling when skull bone was breached.So dura tear in all the 3 holes.The surgery was extended for 30 minutes.The procedure was completed with the reported product.User fixed the dura with specific products.

• Brand Name: IPC® FOOTPEDAL
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I
• 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: 20558736
• Report Number: 1045254-2024-01892
• Device Sequence Number: 3250508
• Product Code: ERL
• UDI-Device Identifier: 00643169931398
• UDI-Public: 00643169931398
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081277
• 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
• Report Date (Section B): 10/29/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1898430
• Device Catalogue Number: 1898430
• Device Lot Number: 228549649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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: 1898001 IPC - SN (B)(6).
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown