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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 12/26/2013
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the core impaction drill was leaking substance that appeared to be oil.None of the leaking substance entered the surgical site.The procedure was completed successfully with no delay; no adverse consequences or medical intervention were reported.
 
Event Description
It was reported that during a procedure at the user facility the core impaction drill was leaking substance that appeared to be oil.None of the leaking substance entered the surgical site.The procedure was completed successfully 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.
 
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.Based on a review of the device ifu, the observed corrosion and reported leaking are likely due to cleaning practices at the account and/or the age of the device.
 
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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 Key3580194
MDR Text Key3988943
Report Number0001811755-2014-00189
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 Dentist
Type of Report Initial,Followup
Report Date 12/26/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2014
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 Manufacturer12/26/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2014
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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