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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 Burn(s) (1757)
Event Date 02/28/2014
Event Type  Injury  
Event Description
It was reported that during a procedure at the user facility the core impaction drill was overheating and the patient received a second degree burn of about 1 cm x 2 cm inside the right corner of the mouth.The procedure was completed successfully without a delay.Aloe gel was placed on the burn to keep the area moist and promote healing.Follow-up visits are still in progress to determine if there will be permanent damage, and additional information will be reported as it becomes available.
 
Manufacturer Narrative
The reported event of overheating was duplicated.Upon disassembly for visual inspection the service technician observed spindle housing corrosion.
 
Manufacturer Narrative
This correction is being filed to update outcomes attributed to the adverse event.
 
Event Description
It was reported that during a procedure at the user facility the core impaction drill was overheating and the patient received a second degree burn of about 1 cm x 2 cm inside the right corner of the mouth.The procedure was completed successfully without a delay.Aloe gel was placed on the burn to keep the area moist and promote healing.Follow-up visits are still in progress to determine if there will be permanent damage, and additional information will be reported as it becomes available.
 
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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
MDR Report Key3703955
MDR Text Key4333660
Report Number0001811755-2014-01045
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
PMA/PMN Number
K040369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,user facility
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2014
Is this an Adverse Event Report? Yes
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 Manufacturer03/07/2014
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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