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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
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/18/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during cleaning, a screw was observed missing.There was no associated procedure and therefore, no patient involvement.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
It was reported that during cleaning, a screw was observed missing.There was no associated procedure and therefore, no patient involvement.
 
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Brand Name
REVOLUTION FRICTION CEMENT GUN
Common Device Name
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8514792
Report Number0001811755-2019-01189
Device Sequence Number1884164
Product Code JDZ
UDI-Device Identifier07613154259793
UDI-Public07613154259793
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/22/2019
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
Operator of Device Health Professional
Device Catalogue Number0606100000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2019
Initial Date Received by Manufacturer 03/18/2019
Supplement Date Received by Manufacturer03/18/2019
Initial Report FDA Received Date04/15/2019
Supplement Report FDA Received Date05/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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