MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION CMS W/ BREAKAWAY FEMORAL NOZZLE, CEMENT APPL. KIT & PROX. MED. PRESS.; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0606705000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the there was small black debris found inside the bottom of a tube and in the bottom of the tray during preparation prior to a procedure.There was no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported that the there was small black debris found inside the bottom of a tube and in the bottom of the tray during preparation prior to a procedure.There was no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
The device was discarded.

• Brand Name: REVOLUTION CMS W/ BREAKAWAY FEMORAL NOZZLE, CEMENT APPL. KIT & PROX. MED. PRESS.
• 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
• MDR Report Key: 8178698
• Report Number: 0001811755-2018-02840
• Device Sequence Number: 16476931
• Product Code: JDZ
• UDI-Device Identifier: 34546540912344
• UDI-Public: 34546540912344
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• 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): 05/13/2019

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 Number: 0606705000
• Device Lot Number: 18191012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1