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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 02/06/2014
Event Type  malfunction  
Event Description
It was reported that the product has the bare wires.There was no associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that the product has the bare wires.There was no associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
 
Manufacturer Narrative
The reported event, exposed bare wires, was not confirmed.During the inspection the tech found that the outer casing of the cord was pulled away from the unit; however, there were no bare wires exposed, as the wire coating was still intact.According to risk documentation and a review of previous complaints with a similar reported event a damaged adaptor cord assembly may have been a result of accidental damage or wear and tear over the life of the device.Device repaired and returned to the customer after passing final inspections.
 
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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 Key3658102
MDR Text Key4353211
Report Number0001811755-2014-00726
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 02/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer02/07/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/02/2014
Initial Date FDA Received03/04/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/05/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2007
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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