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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION CMS W/ CANCELLOUS NOZZLE & TIBIAL PRESS. TIP; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION CMS W/ CANCELLOUS NOZZLE & TIBIAL PRESS. TIP; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0606583000
Medical Device Problem Code Delivered as Unsterile Product (1421)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/31/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device was not available for evaluation.Additional information: 1 device was labeled for single-use.1 device was not reprocessed or reused.Device not returned.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device had debris in sterile package.1 event had patient involvement; no patient impact.
 
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Brand Name
REVOLUTION CMS W/ CANCELLOUS NOZZLE & TIBIAL PRESS. TIP
Common Device Name
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
PR  00615
MDR Report Key9997098
Report Number0001811755-2020-01066
Device Sequence Number17253858
Product Code JDZ
UDI-Device Identifier34546540447907
UDI-Public34546540447907
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/24/2020
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 No Information
Device Catalogue Number0606583000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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