MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO FEMORAL CANAL BRUSH, IRRIGATION/SUCTION; LAVAGE, JET

Catalog Number	0210004000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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: 3 events were reported for this quarter.Product return status: 1 device was received.2 device investigation types have not yet been determined.3 devices were labeled for single-use.3 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device or cutting accessory fractured.3 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: 3 previously reported events are included in this follow-up record.Product return status: 1 device was received.1 device was not available for evaluation.1 device investigation type has not yet been determined.
Event or Problem Description
This report summarizes 3 malfunction events in which the device or cutting accessory fractured.3 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: 3 previously reported events are included in this follow-up record.Product return status: 1 device was received.2 devices were not available for evaluation.
Event or Problem Description
This report summarizes 3 malfunction events in which the device or cutting accessory fractured.3 events had patient involvement; no patient impact.

• Brand Name: FEMORAL CANAL BRUSH, IRRIGATION/SUCTION
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12203304
• Report Number: 3015967359-2021-01455
• Device Sequence Number: 17408781
• Product Code: FQH
• UDI-Device Identifier: 34546540144134
• UDI-Public: 34546540144134
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• 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): 01/17/2022

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: 0210004000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 06/30/2021; 06/30/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 10/26/2021; 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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