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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.0MM CROSS-CUT FISSURE CARBIDE BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.0MM CROSS-CUT FISSURE CARBIDE BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 0277010210
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2023
Event Type  malfunction  
Manufacturer Narrative
H6.: a follow up report will be filed once the quality investigation is complete.H3.Other text : device not returned.
 
Event Description
It was reported that during a procedure, three burs broke while cutting, a piece of the broken burr had to be recovered from the patient's gum, resulting in a thirty minute delay.The procedure was completed successfully; no adverse consequences or medical intervention were reported.This report is for the second bur that broke.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
Event Description
It was reported that during a procedure, three burs broke while cutting, a piece of the broken burr had to be recovered from the patient's gum, resulting in a thirty minute delay.The procedure was completed successfully; no adverse consequences or medical intervention were reported.This report is for the second bur that broke.
 
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Brand Name
1.0MM CROSS-CUT FISSURE CARBIDE BUR
Type of Device
BUR, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
Manufacturer Contact
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
214532900
MDR Report Key16681809
MDR Text Key312710552
Report Number3015967359-2023-00686
Device Sequence Number1
Product Code GFF
UDI-Device Identifier04546540050489
UDI-Public04546540050489
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 05/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0277010210
Device Catalogue Number0277010210
Device Lot Number22209017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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