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	08/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the one of the brushes in the femoral canal brush came apart about 1cm down the brush head and fell into the surgical site of the patient, during a procedure.There was a clinically insignificant delay while the brush was successfully removed from the surgical site of the patient.
Additional Manufacturer Narrative
Confirmed.User related.
Event or Problem Description
The user facility reported that the one of the brushes in the femoral canal brush came apart about 1cm down the brush head and fell into the surgical site of the patient, during a procedure.There was a clinically insignificant delay while the brush was successfully removed from the surgical site of the patient.

• 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: 7888935
• Report Number: 0001811755-2018-01662
• Device Sequence Number: 19298243
• Product Code: FQH
• UDI-Device Identifier: 34546540144134
• UDI-Public: 34546540144134
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: EXEMPT
• 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): 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 09/19/2018
• 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