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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 Consequences Or Impact To Patient (2199)
Event Date 06/06/2014
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the core impaction drill was leaking near the tip of the device.The procedure was completed successfully with no delay,no medical intervention, and no adverse consequences reported.
 
Manufacturer Narrative
The technician was unable to duplicate the reported leaking but noted corrosion inside the spindle housing.A corroded spindle housing can be an indication of stagnant cleaning fluid or other liquid.The observed corrosion and reported leaking are likely due to cleaning practices at the account.
 
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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 Key3913259
MDR Text Key4518174
Report Number0001811755-2014-02387
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 06/06/2014
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? 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 Manufacturer06/17/2014
Date Manufacturer Received06/06/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2010
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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