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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE IMPACTION DRILL; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO CORE IMPACTION DRILL; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5400300000
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 06/09/2014
Event Type  Injury  
Event Description
It was reported that during an extraction procedure at the user facility, the core impaction drill overheated, causing a 2 by 5 centimeter burn to the lower lip of the patient.Neosporin was applied to the burn.No additional medical intervention or adverse consequences were reported.The procedure was completed successfully using back-up equipment without a clinically significant delay.
 
Event Description
It was reported that during an extraction procedure at the user facility, the core impaction drill overheated, causing a 2 by 5 centimeter burn to the lower lip of the patient.Neosporin was applied to the burn.No additional medical intervention or adverse consequences were reported.The procedure was completed successfully using back-up equipment without a clinically significant delay.
 
Manufacturer Narrative
The device is available for evaluation but has not yet been received.Additional information may be submitted once the device is received and the quality investigation is complete.
 
Manufacturer Narrative
Product return updated.As this product was not returned for evaluation, the failure mode could not be confirmed.Device not returned to manufacturer for investigation.
 
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Brand Name
CORE IMPACTION DRILL
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3913258
MDR Text Key4490439
Report Number0001811755-2014-02388
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040369
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 06/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400300000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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