MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP BREAK-AWAY FEMORAL NOZZLE; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0206512000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 5 malfunction events in which the device had a component detach.- 5 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 5 events were reported for this quarter.Product return status 5 device investigation types have not yet been determined.Additional information 5 devices were labeled for single-use.5 devices were not reprocessed or reused.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 5 events were previously reported during the reporting quarter; however, 1 previously reported event was included under mfr report # 3015967359-2023-01713 but should be included under this report.6 previously reported events are included in this follow-up record.Product return status: 4 devices were evaluated based on historical data analysis.2 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 6 malfunction events in which the device had a component detach.6 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 6 malfunction events in which the device had a component detach.6 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 6 previously reported events are included in this follow-up record.Product return status: 1 device was not available for evaluation.5 devices were evaluated based on historical data analysis.

• Brand Name: BREAK-AWAY FEMORAL NOZZLE
• 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-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17397061
• Report Number: 3015967359-2023-01532
• Device Sequence Number: 18072936
• Product Code: JDZ
• UDI-Device Identifier: 34546540039416
• UDI-Public: 34546540039416
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0206512000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 06/30/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 10/25/2023; 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown