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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.2MM CROSS-CUT FISSURE CARBIDE BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.2MM CROSS-CUT FISSURE CARBIDE BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 0277010212
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2022
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available for return.
 
Event Description
It was reported that during incoming inspection at a customer site, it was noted that two burs were broken.It was also reported that this event did not occur during a surgical procedure, and there was no delay, no adverse consequences as a result of this event.This report is for the second bur that broke.
 
Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned, photograph provided.
 
Event Description
It was reported that during incoming inspection at a customer site, it was noted that two burs were broken.It was also reported that this event did not occur during a surgical procedure, and there was no delay, no adverse consequences as a result of this event.This report is for the second bur that broke.
 
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Brand Name
1.2MM 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 Key16404048
MDR Text Key310135710
Report Number3015967359-2023-00446
Device Sequence Number1
Product Code GFF
UDI-Device Identifier04546540050496
UDI-Public04546540050496
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0277010212
Device Catalogue Number0277010212
Device Lot Number20174017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2020
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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