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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION FRICTION CEMENT GUN; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION FRICTION CEMENT GUN; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0606100000
Device Problem Failure to Deliver (2338)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2015
Event Type  malfunction  
Event Description
It was reported that during a procedure the revolution cement gun stopped working.As a result of the event the case was delayed by 40 minutes.There were no adverse consequences or medical intervention reported.
 
Event Description
It was reported that during a procedure, the revolution cement gun stopped working.As a result of the event the case was delayed by 40 minutes.There were no adverse consequences or medical intervention reported.
 
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Brand Name
REVOLUTION FRICTION 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 Key4767949
MDR Text Key19308667
Report Number0001811755-2015-01731
Device Sequence Number1
Product Code JDZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0606100000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/23/2015
Was Device Evaluated by Manufacturer? No
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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