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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ION NITRIDED BLADE; INSTRUMENT, CAST REMOVAL, AC-POWERED
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STRYKER INSTRUMENTS-KALAMAZOO ION NITRIDED BLADE; INSTRUMENT, CAST REMOVAL, AC-POWERED Back to Search Results
Model Number 0940023000
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 10/16/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
 
Event Description
It was reported via the customer that, they observed a broken blade within their inventory.It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement, no delay and no adverse consequences as a result of this event.
 
Manufacturer Narrative
The reported event, for blade breakage, was not confirmed as the blade was not returned for evaluation.Without the blade, the root cause cannot be determined.Device not available for return.
 
Event Description
It was reported via the customer that, they observed a broken blade within their inventory.It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement, no delay and no adverse consequences as a result of this event.
 
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Brand Name
ION NITRIDED BLADE
Type of Device
INSTRUMENT, CAST REMOVAL, AC-POWERED
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9318736
MDR Text Key166429250
Report Number0001811755-2019-03758
Device Sequence Number1
Product Code LGH
UDI-Device Identifier04546540132253
UDI-Public04546540132253
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0940023000
Device Catalogue Number0940023000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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