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

Model Number XOM UNK DRILLBUR

Device Problems Break (1069); Fitting Problem (2183); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

H3: visually, the bur tang was dislodged from the proximal end of a curved bur when returned.The length of the bur tang shall be 0.750 ± 0.005 inches and the actual measurement was 0.748 inches.The outside diameter of the distal end of the bur tang shall be 0.0919 ± 0.000 inches and the actual measurement was 0.0921 inches.The outside diameter of the proximal end of the bur tang shall be 0.056 ± 0.002 inches and the actual measurement was 0.056 inches.All the dimensional measurements were in specification.Functional testing could not be performed due to the broken state of the device.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.

Event Description

A health care professional reported that prior to use, bur was not seating flush in visao handpiece.There was no patient impact.Analysis of handpiece found that there was a broken bur stuck in handpiece.

• Brand Name: XPS® BUR - UNKNOWN
• Type of Device: 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: 19150777
• MDR Text Key: 340680420
• Report Number: 1045254-2024-00587
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: XOM UNK DRILLBUR
• Device Catalogue Number: XOM UNK DRILLBUR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1