MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP FEMORAL CANAL TIP, IRRIGATION/SUCTION; LAVAGE, JET

Catalog Number	0210008000
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	09/30/2022
Type of Reportable Event	Malfunction
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.5 devices were labeled for single-use.5 devices were reprocessed or reused.
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.Supplemental rationale: 5 previously reported events are included in this follow-up record.Product return status: 5 devices were not available for evaluation.Additional information: 5 devices were not reprocessed or reused.
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.Supplemental rationale corrected data: b5, h6, h10 5 events were previously reported during the reporting period; however, - 5 previously reported events in this report should have been included under mfr report # 3015967359-2022-02077.- 0 previously reported events are included in this follow-up record.Additional information 0 devices were labeled for single-use.0 devices were not reprocessed or reused.H3 other text : events reported on mfr report # 3015967359-2022-02077.
Event or Problem Description
This report summarizes 0 malfunction events in which the device had a component detach.

• Brand Name: FEMORAL CANAL TIP, IRRIGATION/SUCTION
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; highway #3, km 130.2; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo MI 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15663728
• Report Number: 3015967359-2022-02006
• Device Sequence Number: 15070492
• Product Code: FQH
• UDI-Device Identifier: 34546540144158
• UDI-Public: 34546540144158
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• 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: 0210008000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 09/30/2022; 09/30/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/30/2023; 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