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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.2MM TAPER SIDE CUTTING CARBIDE BUR; BUR, DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO 1.2MM TAPER SIDE CUTTING CARBIDE BUR; BUR, DENTAL Back to Search Results
Catalog Number 1607002105
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/16/2016
Event Type  malfunction  
Manufacturer Narrative
Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that during a surgical procedure while cutting teeth, the bur broke in the attachment.It was also reported there were no adverse consequences as a result of this event.It was also reported the procedure was completed successfully.
 
Manufacturer Narrative
Investigation results indicate that the damage observed on the flute edges along with the starting point of the fracture would suggest that the part was pulled and pried resulting in the break observed.The fracture failed due to overload conditions which are not consistent with normal use.The ifu's for handpiece associated with the device state the following: "do not apply excessive pressure, such as bending or prying.Excessive pressure may bend or fracture the bur and result in tissue damage, loss of tactile control, and/or the ejection of bur fragments at a high velocity".
 
Event Description
It was reported that during a surgical procedure while cutting teeth, the bur broke in the attachment.It was also reported there were no adverse consequences as a result of this event.It was also reported the procedure was completed successfully.
 
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Brand Name
1.2MM TAPER SIDE CUTTING CARBIDE BUR
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
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key5951949
MDR Text Key54755700
Report Number0001811755-2016-02229
Device Sequence Number1
Product Code EJL
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 08/02/2017
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 Expiration Date01/01/2021
Device Catalogue Number1607002105
Device Lot Number16011017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/18/2016
Initial Date FDA Received09/15/2016
Supplement Dates Manufacturer Received07/28/2017
Supplement Dates FDA Received08/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2016
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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