MAUDE Adverse Event Report: STRYKER INSTRUMENTS ACM BIO PREP CEMENT APPLICATION KIT; MIXER, CEMENT, FOR CLINICAL USE

Model Number 0306-705-000

Device Problem Defective Device (2588)

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

Event Date 03/26/2021

Event Type  malfunction  

Event Description

The stryker acm bio prep cement application kit failed again.After the powder and monomer are mixed, the hatch in the unit fails to open.Fda safety report id# (b)(4).

• Brand Name: ACM BIO PREP CEMENT APPLICATION KIT
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 11700799
• MDR Text Key: 246756995
• Report Number: MW5100897
• Device Sequence Number: 1
• Product Code: JDZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0306-705-000
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR