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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 Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 04/08/2014
Event Type  malfunction  
Event Description
The core impaction drill was returned to stryker instruments for service.Upon receipt at the manufacturer facility, it was found that the device was covered in an oily liquid.No medical intervention and no adverse consequences were reported with this event.As this event occurred at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
The reported event was duplicated.Upon disassembly for visual inspection the service technician observed the spindle housing with corrosion or debris.
 
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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 Key3789687
MDR Text Key4437419
Report Number0001811755-2014-01603
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 Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5400300000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2014
Date Manufacturer Received04/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2009
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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