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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DUAL SPEED CEMENT INJECTION GUN; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO DUAL SPEED CEMENT INJECTION GUN; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0206600000
Device Problem Disassembly (1168)
Patient Problem No Patient Involvement (2645)
Event Date 02/20/2014
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the manufacturer facility that the head of screw on the dual speed cement injection gun was found to be missing.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.
 
Event Description
It was reported that during testing conducted at the manufacturer facility that the head of screw on the dual speed cement injection gun was found to be missing.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
During the device evaluation, one of the cartridge interface screws was observed to be broken off, and corrosion was observed at the ram bushings.The device was repaired and returned to the user facility.
 
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Brand Name
DUAL SPEED CEMENT INJECTION 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 Key3907694
MDR Text Key4664848
Report Number0001811755-2014-02371
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 Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
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 Other
Device Catalogue Number0206600000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/07/2014
Initial Date FDA Received07/01/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2005
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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