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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE IMPACTION DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE IMPACTION DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400300000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Codes Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/02/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device overheated. attempts are being made to obtain additional information about the event; no further information has been received.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the device overheated. the patient received a small burn on the inside of the cheek and the user also received a small burn on the hand.No further adverse consequences were reported.
 
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Brand Name
CORE IMPACTION DRILL
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key11002409
Report Number0001811755-2020-03425
Device Sequence Number3478304
Product Code ERL
UDI-Device Identifier04546540402035
UDI-Public04546540402035
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number5400300000
Device Catalogue Number5400300000
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 12/02/2020
Supplement Date Received by Manufacturer12/02/2020
Initial Report FDA Received Date12/14/2020
Supplement Report FDA Received Date04/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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