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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION CEMENT GUN; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION CEMENT GUN; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0606600000
Device Problem Disassembly (1168)
Patient Problem No Information (3190)
Event Date 02/14/2014
Event Type  malfunction  
Event Description
It was reported by the user facility that the knob was missing from the revolution cement gun.Further information was not provided by the user facility.
 
Manufacturer Narrative
Upon visual inspection, the back pawl was found to be corroded.The device was repaired and returned to the user facility.
 
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Brand Name
REVOLUTION CEMENT GUN
Type of Device
MIXER, CEMENT, FOR CLINICAL USE
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 Key3672044
MDR Text Key15121030
Report Number0001811755-2014-00826
Device Sequence Number1
Product Code JDZ
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
Report Date 02/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0606600000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2014
Initial Date Manufacturer Received 02/20/2014
Initial Date FDA Received03/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2004
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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