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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Date 08/31/2015
Event Type  malfunction  
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.
 
Event Description
It was reported that during a procedure at the user facility the patient was scratched a 1cm in size by the device.No additional treatment expected, no scar, and no infection were reported with this event.
 
Manufacturer Narrative
No known device problem was found.Device was returned to the customer.
 
Event Description
It was reported that during a procedure at the user facility the patient was scratched a 1cm in size by the device.No additional treatment expected, no scar, and no infection were reported 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
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 Key5091579
MDR Text Key26324338
Report Number0001811755-2015-03447
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Risk Manager
Type of Report Followup
Report Date 08/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0940000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received10/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2004
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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