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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE HELMET; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE HELMET; HELMET, SURGICAL Back to Search Results
Catalog Number 0408600000
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 01/31/2014
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the user facility the device was overheating.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
 
Event Description
It was reported that during testing conducted at the user facility the device was overheating.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
 
Event Description
It was reported that during testing conducted at the user facility, the device was overheating.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
 
Manufacturer Narrative
The reported overheating was not able to be duplicated by a manufacturer repair technician through functional evaluation.Upon disassembly for visual examination, no components were identified which would have likely caused or contributed to the reported failure.The helmet is not a repairable device and will therefore not be returned to the user facility.
 
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Brand Name
FLYTE HELMET
Type of Device
HELMET, SURGICAL
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 Key3653511
MDR Text Key4195211
Report Number0001811755-2014-00689
Device Sequence Number1
Product Code FXZ
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,Followup
Report Date 02/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0408600000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received06/19/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2013
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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