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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BATTERY CHARGER, 120 VOLT"; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO BATTERY CHARGER, 120 VOLT"; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4110120000
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 06/02/2014
Event Type  malfunction  
Event Description
It was reported that the device is overheating during charging at user facility.Smoke and burning smell was coming out of the charger and the plastic of the battery was melted.No flames were visible.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device has been received, but the evaluation has not yet begun.Additional information may be submitted once the quality investigation is complete.
 
Event Description
It was reported that the device is overheating during charging at user facility.Smoke and burning smell was coming out of the charger and the plastic of the battery was melted.No flames were visible.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported event, charger overheating and was smoking, was not duplicated, however it was confirmed that plastic on the charger had melted.The engineer determined that the cause of the overheating was most likely caused by faulty batteries.The ifu also advises users not to place a battery in a module until the module is connected to the charger.Failure to do so can cause the module to become hot with the potential to burn.Device was repaired and returned to customer.
 
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Brand Name
BATTERY CHARGER, 120 VOLT"
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-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 Key3899552
MDR Text Key16555680
Report Number0001811755-2014-02286
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4110120000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/07/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2003
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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