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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 UNK M-BUR-BLD
Device Problems Break (1069); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A healthcare provider (hcp) reported that the drill with the curved tip keeps breaking mid procedure. When they attempt to change the tip, it also gets jammed in the drill. 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 Key12275453
MDR Text Key265000119
Report Number1045254-2021-00427
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeCA
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,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXOM UNK M-BUR-BLD
Device Catalogue NumberXOM UNK M-BUR-BLD
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 Received08/03/2021
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

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