MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP ACM; MIXER, CEMENT, FOR CLINICAL USE

Model Number 0306563000

Device Problems Activation, Positioning or Separation Problem (2906); Material Split, Cut or Torn (4008)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

The stryker acm bowl and cement cartridge with breakaway femoral nozzle (model/catalog #0306-563-000; lot #22202012) was used during a case and when hooked up, it wouldn't hold pressure.When the time came for the cement tab to be pulled so that the cement was pulled into the chamber, we had to keep pumping to assist with removal of bubbles form the cement.At the end of the case, we looked at the tubing and there were cinch marks/ cuts into the tubing that looked like it was from where the metal twist tie was.

• Brand Name: ACM
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 15968704
• MDR Text Key: 305347440
• Report Number: 15968704
• Device Sequence Number: 1
• Product Code: JDZ
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0306563000
• Device Catalogue Number: 0306563000
• Device Lot Number: 22202012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1