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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 06/17/2014
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 using back-up equipment with no delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
 
Event Description
It was reported that during a procedure at the user facility, the core impaction drill was overheating.The procedure was completed successfully using back-up equipment with no delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
The reported event was duplicated.Upon disassembly for visual inspection, the service technician observed bearing corrosion.
 
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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 Key3932805
MDR Text Key4601702
Report Number0001811755-2014-02499
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 06/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2014
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 Manufacturer06/20/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/25/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2010
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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