MAUDE Adverse Event Report: STRYKER CORPORATION ACM BOWL AND CEMENT CARTRIDGE WITH BREAKAWAY FEMORAL NOZZLE; MIXER, CEMENT, FOR CLINICAL USE

Model Number 0306563000

Device Problems Crack (1135); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2022

Event Type  malfunction  

Event Description

Our cement mixer was found to have a crack in it resulting in pressure issues with our nitrogen mixing of the cement.We had to exit the room, gather more supplies, thus increasing infection risk.Lot number 21306012, stryker acm bowl and cement cartridge with breakaway femoral nozzle product reference 0306-563-000.

• Brand Name: ACM BOWL AND CEMENT CARTRIDGE WITH BREAKAWAY FEMORAL NOZZLE
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 15454409
• MDR Text Key: 300241676
• Report Number: 15454409
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 04546540055408
• UDI-Public: 04546540055408
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0306563000
• Device Catalogue Number: 0306563000
• Device Lot Number: 21306012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1