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

Catalog Number	0606563000
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported when opening up the package, the inside wrap/packaging was stuck to outside wrap.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Additional information added for d4, d10, h3, h4 device evaluation: follow-up report submitted to document device evaluation results.H3 other text : device discarded.
Event or Problem Description
The user facility reported when opening up the package, the inside wrap/packaging was stuck to outside wrap.There was no patient involvement, 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-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• MDR Report Key: 8940954
• Report Number: 0001811755-2019-02829
• Device Sequence Number: 19479152
• Product Code: JDZ
• UDI-Device Identifier: 34546540912092
• UDI-Public: 34546540912092
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/22/2020

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: Health Professional
• Device Catalogue Number: 0606563000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1