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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 Device Remains Activated (1525)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/04/2016
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility that the device would not shut off. The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Upon completion of the device evaluation it was determined that the device only had a loss of function, and that the event of the device unable to shut-off was reported in error. The event of a loss of function is not likely to result in serious injury or death.
 
Event Description
It was reported that during a procedure at the user facility that the device loss function. The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand NameCAST CUTTER
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5385293
MDR Text Key36636423
Report Number0001811755-2016-00090
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0940000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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