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

Model Number	0206500000
Medical Device Problem Codes	Decrease in Pressure (1490); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Additional information: d9 h3 other text : device not returned by customer.
Event or Problem 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
• 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17321813
• Report Number: 3015967359-2023-01444
• Device Sequence Number: 6524472
• Product Code: JDZ
• UDI-Device Identifier: 04546540039378
• UDI-Public: 04546540039378
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 0206500000
• Device Catalogue Number: 0206500000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown