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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER, 8 FOOT CORD "; SAW, POWERED, AND ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO CAST CUTTER, 8 FOOT CORD "; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0840000000
Device Problems Overheating of Device (1437); Failure to Shut Off (2939)
Patient Problem No Patient Involvement (2645)
Event Date 08/03/2014
Event Type  malfunction  
Event Description
It was reported that the cast is overheating and it failed to shut off prior to a cast removal procedure.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 is overheating and it failed to shut off prior to a cast removal procedure.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device has not been received at the manufacturer for testing. an evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
 
Manufacturer Narrative
Device was not returned to the manufacturer for evaluation.
 
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Brand Name
CAST CUTTER, 8 FOOT 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 Key4213393
MDR Text Key5150248
Report Number0001811755-2014-03848
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 10/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0840000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2009
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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