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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE LARGE ASPTC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE LARGE ASPTC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 7126120000
Device Problems Component Missing (2306); Device Disinfection Or Sterilization Issue (2909); Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 01/20/2015
Event Type  malfunction  
Event Description
It was reported that during inspection at the manufacturer facility, the top housing and door of the device were found to be missing, and the device hinge was broken.In this state the device could not close properly, with the potential to expose a non-sterile battery to a surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
Event Description
It was reported that during inspection at the manufacturer facility, the top housing and door of the device were found to be missing, and the device hinge was broken.In this state the device could not close properly, with the potential to expose a non-sterile battery to a surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred at the manufacturer facility, 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.Failure analysis is in progress.
 
Manufacturer Narrative
The reported event, housing lid/door missing and hinge broken, was confirmed.The service technician/specialist found that the top housing was missing.The tech determined the housing hinge was broken and the door was missing.As this is not a repairable device, it was not returned to the customer.
 
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Brand Name
SMARTLIFE LARGE ASPTC HOUSING
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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 Key4518637
MDR Text Key5489352
Report Number0001811755-2015-00518
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7126120000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received05/08/2015
Was Device Evaluated by Manufacturer? Yes
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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