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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORDLESS DRIVER 3 HANDPIECE; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO CORDLESS DRIVER 3 HANDPIECE; ARTHROSCOPE Back to Search Results
Catalog Number 4300000000
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 08/29/2016
Event Type  malfunction  
Event Description
It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility the device had an unexpected power surge.As this event occurred during testing at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
CORDLESS DRIVER 3 HANDPIECE
Type of Device
ARTHROSCOPE
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 Key5972580
MDR Text Key55426973
Report Number0001811755-2016-02355
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number4300000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2016
Date Manufacturer Received08/29/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/30/2009
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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