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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE SAG SAW; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE SAG SAW; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400034000
Medical Device Problem Codes Unintended Power Up (1162); Overheating of Device (1437)
Health Effect - Clinical Codes No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/19/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device was running without activation during testing prior to a procedure. attempts were made to obtain additional information about the event; no further information was received.
 
Event or Problem Description
The user facility reported that the device was running without activation during testing prior to a procedure.  there were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Additional info b5 device evaluation: follow-up report submitted to document device evaluation results.
 
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Brand Name
CORE SAG SAW
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 Key10100986
Report Number0001811755-2020-01345
Device Sequence Number14331258
Product Code ERL
UDI-Device Identifier04546540401953
UDI-Public04546540401953
Combination Product (Y/N)N
Initial Reporter CountryGB
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) 09/17/2020
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 Number5400034000
Device Catalogue Number5400034000
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 05/19/2020
Supplement Date Received by Manufacturer09/17/2020
Initial Report FDA Received Date05/29/2020
Supplement Report FDA Received Date09/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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