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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER, 18 INCH CORD "; SAW, POWERED, AND ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER, 18 INCH CORD "; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0848000000
Device Problem Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2014
Event Type  malfunction  
Event Description
It was reported that the cast cutter was sparking during a cast removal procedure at the user facility.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that the cast cutter was sparking during a cast removal procedure at the user facility.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.Evaluation is in progress.
 
Manufacturer Narrative
The reported event, the device sparked and blade stopped rotating, was duplicated.Device was repaired and preventative maintenance was performed and the device was returned to the customer.
 
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Brand Name
CAST CUTTER, 18 INCH CORD "
Type of Device
SAW, 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 Key4245351
MDR Text Key5047613
Report Number0001811755-2014-04049
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 Other
Type of Report Initial,Followup
Report Date 10/16/2014
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 Health Professional
Device Catalogue Number0848000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/24/2014
Initial Date FDA Received11/12/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/02/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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