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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT

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MEDTRONIC XOMED INC. MICRODEBRIDER BLADES AND BURS BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number XOM UNKNOWN BLADE
Device Problems Vibration (1674); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A healthcare professional (hcp) reported that the blade wobbled in the handpiece. The milling filler neck was loose and milling cannot be detected. There was no patient impact.
 
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Brand NameMICRODEBRIDER BLADES AND BURS
Type of DeviceBUR, 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
david gustafson
6743 southpoint drive north
jacksonville, FL 32216
7635149628
MDR Report Key12196460
MDR Text Key262454698
Report Number1045254-2021-00381
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXOM UNKNOWN BLADE
Device Catalogue NumberXOM UNKNOWN BLADE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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