MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP AUTOMATIC HIGH VACUUM FOOT PUMP; MIXER, CEMENT, FOR CLINICAL USE

Model Number 0206500000

Device Problems Decrease in Pressure (1490); Insufficient Information (3190)

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

Event Date 05/18/2023

Event Type  Injury  

Event Description

The user facility reported that during a procedure they mixed and applied cement in a patient according to the manufacturer's instructions, but found the mixing didn't work and cement consistency was not correct.Surgeon had to remove all applied cement which led to a 30 minute case delay.A second batch of cement was used and mixed correctly.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional information: d9 h3 other text : device not returned by customer.

Event Description

The user facility reported that during a procedure they mixed and applied cement in a patient according to the manufacturer's instructions, but found the mixing didn't work and cement consistency was not correct.Surgeon had to remove all applied cement which led to a 30 minute case delay.A second batch of cement was used and mixed correctly.There were no adverse consequences to the patient.

• Brand Name: AUTOMATIC HIGH VACUUM FOOT PUMP
• Type of Device: 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17321813
• MDR Text Key: 319011479
• Report Number: 3015967359-2023-01444
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 04546540039378
• UDI-Public: 04546540039378
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0206500000
• Device Catalogue Number: 0206500000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other