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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CROSS-CUT FISSURE BUR, LONG ROUND END TAPERED"; BUR, DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO CROSS-CUT FISSURE BUR, LONG ROUND END TAPERED"; BUR, DENTAL Back to Search Results
Catalog Number 2296100421
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 09/30/2014
Event Type  malfunction  
Event Description
It was reported that during testing the bur broke in half, half of the bur remained stuck in the drill and the other half became embedded in the wall.There was no associated procedure and no patient impact as a result of this event.
 
Manufacturer Narrative
The bur and handpiece drill (5400300000 sn (b)(4)) subject to this investigation were returned to the manufacturer for evaluation.It was visually confirmed that the bur was broken along the shank.No further device inspection was possible as the bur could not be removed from the attachment.Based on review of the information provided in relation to this reported event and as device inspection of the affected product is not possible, the root cause of this event is undetermined.
 
Event Description
It was reported that during testing the bur broke in half, half of the bur remained stuck in the drill and the other half became embedded in the wall.There was no associated procedure and no patient impact as a result of this event.
 
Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.Device not yet returned to manufacturer.
 
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Brand Name
CROSS-CUT FISSURE BUR, LONG ROUND END TAPERED"
Type of Device
BUR, DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
Manufacturer Contact
dervillia murphy
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key4188440
MDR Text Key5664395
Report Number0001811755-2014-03690
Device Sequence Number1
Product Code EJL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/30/2014
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 Catalogue Number2296100421
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/15/2015
Initial Date FDA Received10/21/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/23/2015
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 Number1
Treatment
UNKNOWN BUR GUARD; 5400300000 SN (B)(4); 5400300000 LOT (B)(4)
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