MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 180-GRAM CEMENT CARTRIDGE WITH BREAKAWAY FEMORAL NOZZLE; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0206530000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure at the user facility the surgeon placed the long nozzle down the femoral canal during cementing and it instantly snapped.The broken nozzle was retrieved from the patient.Back-up equipment was used to complete the procedure.No clinically significant delay, no adverse consequences and no additional medical intervention was reported.
Event or Problem Description
It was reported that during a procedure at the user facility the surgeon placed the long nozzle down the femoral canal during cementing and it instantly snapped.The broken nozzle was retrieved from the patient.Back-up equipment was used to complete the procedure.No clinically significant delay, no adverse consequences and no additional medical intervention was reported.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.H3 other text : not available.

• Brand Name: 180-GRAM CEMENT CARTRIDGE WITH BREAKAWAY FEMORAL NOZZLE
• 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: 16688227
• Report Number: 3015967359-2023-00692
• Device Sequence Number: 5921434
• Product Code: JDZ
• UDI-Device Identifier: 34546540857881
• UDI-Public: 34546540857881
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: 0206530000
• Device Lot Number: 22089012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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