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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 Laceration(s) (1946)
Event Date 05/21/2015
Event Type  Malfunction  
Event Description

It was reported that during a cast removal at the user facility, the device nicked a patient. The procedure was completed successfully. No delay, no medical intervention, and no adverse consequences were reported with this event.

 
Manufacturer Narrative

The device is available for evaluation but has not yet been received. Additional information will be submitted once the device is received and the quality investigation is complete. The device has not been returned for analysis at this time.

 
Manufacturer Narrative

No failure related to this complaint was found upon device evaluation. Preventative maintenance was performed, and the device was returned to the customer.

 
Event Description

It was reported that during a cast removal at the user facility the device nicked a patient. The procedure was completed successfully. No delay, no medical intervention, and no adverse consequences were reported with this event.

 
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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 Key4892691
MDR Text Key6536274
Report Number0001811755-2015-02424
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User facility,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/06/2015
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 Manufacturer07/20/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/19/1992
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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