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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
Catalog Number 0940023000
Device Problem Excessive Heating (4030)
Patient Problem Burn(s) (1757)
Event Date 08/08/2018
Event Type  malfunction  
Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that following removal of a cast from a infants arm, burn marks were observed on the patients arm.It was also reported that the event did not cause a delay and the procedure was completed successfully.
 
Manufacturer Narrative
The reported event, for burn, as a result of the use of the ion nitrided blade, was not confirmed as the ion nitrided blade was not returned for evaluation.Without the ion nitrided blade, the root cause cannot be determined.Device not available for return.
 
Event Description
It was reported that following removal of a cast from a infants arm, burn marks were observed on the patients arm.It was also reported that the event did not cause a delay and the procedure was completed successfully.
 
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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 Key7847431
MDR Text Key119333879
Report Number0001811755-2018-01637
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 health professional
Type of Report Initial,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0940023000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
0940000000 S/N: (B)(4); 0986000000 S/N: (B)(4)
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