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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 Problems Laceration(s) (1946); Therapeutic Effects, Unexpected (2099)
Event Date 03/26/2015
Event Type  Injury  
Event Description

It was reported that during a cast removal procedure at the user facility the patient sustained a 3 cm cut at the right navicular. The cast removal was completed successfully. The wound was closed with sutures. An x-ray was obtained, which showed no bony abnormality or fracture.

 
Manufacturer Narrative

This event was reported by the user facility as uf/importer report # (b)(4). The device was not returned for analysis.

 
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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 Key4843438
MDR Text Key5868461
Report Number0001811755-2015-02142
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
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 05/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0940000000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/26/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/15/2015 Patient Sequence Number: 1
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