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
Additional Manufacturer Narrative
H3 other text : not available.
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.

• 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: 16961478
• Report Number: 3015967359-2023-01137
• Device Sequence Number: 14758549
• 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