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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 No Consequences Or Impact To Patient (2199)
Event Date 06/03/2014
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the core impaction drill was overheating.The procedure was completed successfully without a clinically significant delay; no medical intervention and no adverse consequences were reported.
 
Manufacturer Narrative
The technician was able to duplicate the reported event and noted that the driveshaft bearing was damaged.
 
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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 Key3902163
MDR Text Key20457083
Report Number0001811755-2014-02318
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
Report Date 06/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400300000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2014
Date Manufacturer Received06/03/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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