MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1882969
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bur broken during optic nerve decompression surgery.The procedure was delayed up to 15 minutes. the procedure was completed with backup product.There was no injury.Additional information received that the bur tip was broken while being used on a patient.The fragments inside the patient's body were removed with operating room forceps without leaving any residue.It was the consumable that was damaged, not the device, so there were no pieces falling off the damaged device.Because this consumable was used to connect the device, there was no problem with the device.The consumable broke and fell off and had been completely removed.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 bur broken during optic nerve decompression surgery.The procedure was delayed up to 15 minutes. the procedure was completed with backup product.There was no injury.Additional information received that the bur tip was broken while being used on a patient.The fragments inside the patient's body were removed with operating room forceps without leaving any residue.It was the consumable that was damaged, not the device, so there were no pieces falling off the damaged device.Because this consumable was used to connect the device, there was no problem with the device.The consumable broke and fell off and had been completely removed.
Additional Manufacturer Narrative
H3: product analysis: visually, the inner spiral wrap was broken 0.80 inches from the distal end of the distal diamond grit tip when returned.There were portions of the outer tube that were broken off on the distal end and striations on the outside diameter of the inner shaft 0.69 inches from the distal end of the inner hub.Additionally, the inner hub washer was unadhered from the hub assembly and there was contamination compacted onto the tip and the outside diameter of the outer tube.Functional testing could not be performed due to the broken state of the device.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).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: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• 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: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 18956820
• Report Number: 1045254-2024-00398
• Device Sequence Number: 9364433
• Product Code: EQJ
• UDI-Device Identifier: 00681490613279
• UDI-Public: 00681490613279
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/22/2024

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 Expiration Date: 06/02/2026
• Device Model Number: 1882969
• Device Catalogue Number: 1882969
• Device Lot Number: 0215584276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2018
• 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 Sex: Unknown