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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER; SAW, POWERED, AND ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0940000000
Device Problem Unintended Power Up (1162)
Patient Problem No Patient Involvement (2645)
Event Date 01/16/2019
Event Type  malfunction  
Event Description
It was reported after a procedure at the user facility that the device would not turn off.The procedure was completed successfully without a clinically significant delay.No adverse consequences were associated with this event.
 
Manufacturer Narrative
Supplemental submitted to document device evaluation.
 
Event Description
It was reported after a procedure at the user facility that the device would not turn off.The procedure was completed successfully without a clinically significant delay.No adverse consequences were associated with this event.
 
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Brand Name
CAST CUTTER
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8323288
MDR Text Key135707632
Report Number0001811755-2019-00519
Device Sequence Number1
Product Code HAB
UDI-Device Identifier07613327115147
UDI-Public07613327115147
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/25/2019
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
Device Operator No Information
Device Catalogue Number0940000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Initial Date Manufacturer Received 01/17/2019
Initial Date FDA Received02/08/2019
Supplement Dates Manufacturer Received03/18/2019
Supplement Dates FDA Received03/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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