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

Catalog Number	0210004000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the brush broke during a procedure.There was no patient impact, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Upon visual inspection, the reported condition was confirmed.The most probable root cause for the reported condition is user related.
Event or Problem Description
The user facility reported that the brush broke during a procedure.There was no patient impact, no medical intervention, and no adverse consequences.

• 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
• MDR Report Key: 8048070
• Report Number: 0001811755-2018-02414
• Device Sequence Number: 19246116
• Product Code: FQH
• UDI-Device Identifier: 34546540144134
• UDI-Public: 34546540144134
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0210004000
• Device Lot Number: 18110012
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 82