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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION CMS W/BREAKAWAY; MIXER, CEMENT FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION CMS W/BREAKAWAY; MIXER, CEMENT FOR CLINICAL USE Back to Search Results
Catalog Number 0606563000
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2014
Event Type  malfunction  
Event Description
It was reported during a total hip procedure when connected with the drill, a piece was observed to break off the revolution cement mixer.The procedure was completed successfully with no patient or user injuries and no adverse consequences.
 
Manufacturer Narrative
It was confirmed by the manufacturer sales representative with the user facility, this product was not malfunctioning and was returned with product reported under mfr report# 0001811755-2014-04260, stryker ref # (b)(4) to trade-in.The device was scrapped at the manufacturer.Sent in by customer for trade-in; no product issue.
 
Event Description
It was reported during a total hip procedure when connected with the drill, a piece was observed to break off the revolution cement mixer.The procedure was completed successfully with no patient or user injuries and no adverse consequences.
 
Manufacturer Narrative
A follow up report will be filed after the device is received and the quality investigation has been completed.Not yet received by manufacturer.
 
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Brand Name
REVOLUTION CMS W/BREAKAWAY
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-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4275229
MDR Text Key14879434
Report Number0001811755-2014-04263
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,Followup
Report Date 10/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0606563000
Device Lot Number14258012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/15/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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