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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 230V CAST CUTTER SAW, POWERED, AND ACCESSORIES

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STRYKER INSTRUMENTS-KALAMAZOO 230V CAST CUTTER SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 0941000000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Date 09/01/2015
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 at the user facility the device scratched a patient and cut a user. No medical intervention was required, no scar, and no infection were reported with this event.

 
Event Description

It was reported that during a procedure at the user facility that the device scratched a patient and cut a user. The scratch and cut were treated with a warm compress. The procedure was completed successfully without a clinically significant delay. No additional medical intervention was reported as a result of the event.

 
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Brand Name230V CAST 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 Key5134891
MDR Text Key27784215
Report Number0001811755-2015-03674
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0941000000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/02/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/13/2013
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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