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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 Appropriate Term/Code Not Available (3191)
Patient Problem Abrasion (1689)
Event Date 05/14/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that following the removal of a cast it was observed that the customer was cut or burned.No further information was provided.
 
Manufacturer Narrative
Investigation results indicate that excessive use of the blade along with using the handpiece in a continuous linear motion may have contributed to the abrasion.The ifu for cast cutter blades has the following warning; ¿cut with an up and down motion.Straight cutting may cut or burn the patient.¿ the quality investigation is complete.
 
Event Description
It was reported that following the removal of a cast it was observed that the customer was cut or burned.No further information was provided.
 
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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 Key8687208
MDR Text Key147604720
Report Number0001811755-2019-01950
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 company representative
Type of Report Initial,Followup
Report Date 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0940023000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Date Manufacturer Received08/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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