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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TITANIUM NITRIDED BLADE; INSTRUMENT, CAST REMOVAL, AC-POWERED
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STRYKER INSTRUMENTS-KALAMAZOO TITANIUM NITRIDED BLADE; INSTRUMENT, CAST REMOVAL, AC-POWERED Back to Search Results
Catalog Number 0940035000
Device Problem Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2015
Event Type  malfunction  
Event Description
It was reported that the blade went dull after removing 3 casts.It was also reported that when trying to remove the fourth cast, it was noted that the teeth on the blade were worn down.It was also reported there were no adverse consequences as a result of this event, the procedure was completed successfully without delay.
 
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not yet returned to manufacturer.
 
Manufacturer Narrative
A dhr (device history record) review of the manufacturing data during the manufacture of this blade indicated that the blade met all manufacturing specifications.Measurements performed on the returned blade against part print specification indicated that the blade met all measurements performed.
 
Event Description
It was reported that the blade went dull after removing 3 casts.It was also reported that when trying to remove the fourth cast, it was noted that the teeth on the blade were worn down.It was also reported there were no adverse consequences as a result of this event, the procedure was completed successfully without delay.
 
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Brand Name
TITANIUM NITRIDED BLADE
Type of Device
INSTRUMENT, CAST REMOVAL, AC-POWERED
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
Manufacturer Contact
dervillia murphy
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key4927109
MDR Text Key6032281
Report Number0001811755-2015-02631
Device Sequence Number1
Product Code LGH
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,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0940035000
Device Lot Number15140017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2015
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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