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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE SABER DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE SABER DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400120000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Codes No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/21/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device overheated during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the device overheated during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
 
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Brand Name
CORE SABER 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 Key9447272
Report Number0001811755-2019-04006
Device Sequence Number2167878
Product Code ERL
UDI-Device Identifier04546540402011
UDI-Public04546540402011
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 05/20/2021
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 Number5400120000
Device Catalogue Number5400120000
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 11/21/2019
Supplement Date Received by Manufacturer05/20/2021
Initial Report FDA Received Date12/10/2019
Supplement Report FDA Received Date05/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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