MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE & ADV. FEM. PRESS.; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0606593000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the bottom of device canister has broken entering the holder with no excess force during a procedure.Femoral canal had to be scraped out with a curette to remove the cement that went into the femoral canal and re-prepped ready for the next lot of cement.The procedure was completed successfully, without a clinically significant delay; no adverse consequences were reported.
Additional Manufacturer Narrative
H3 other text : not available.

• Brand Name: REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE & ADV. FEM. PRESS.
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16961480
• Report Number: 3015967359-2023-01138
• Device Sequence Number: 12068477
• Product Code: JDZ
• UDI-Device Identifier: 34546540447914
• UDI-Public: 34546540447914
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0606593000
• Device Lot Number: 23041012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown