MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0606563000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer discarded product.
Event or Problem Description
The user facility reported while mixing the cement, plastic was shaving off from the top of the device.There was no delay, no medical intervention, and no adverse consequences.

• Brand Name: REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE
• 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: 8748327
• Report Number: 0001811755-2019-02168
• Device Sequence Number: 2338881
• Product Code: JDZ
• UDI-Device Identifier: 34546540912092
• UDI-Public: 34546540912092
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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: 0606563000
• Device Lot Number: 19122012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1