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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO FEMORAL CANAL BRUSH, IRRIGATION/SUCTION; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO FEMORAL CANAL BRUSH, IRRIGATION/SUCTION; LAVAGE, JET Back to Search Results
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 08/19/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the plastic femoral brush lost bristles when used in the femoral canal during a procedure.There was no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the plastic femoral brush lost bristles when used in the femoral canal during a procedure.There was no delay, no medical intervention, and no adverse consequences.
 
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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 Key8941046
Report Number0001811755-2019-02840
Device Sequence Number328332
Product Code FQH
UDI-Device Identifier34546540144134
UDI-Public34546540144134
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 12/13/2019
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 Number0210004000
Device Lot Number18064012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Initial Date Received by Manufacturer 08/19/2019
Supplement Date Received by Manufacturer12/12/2019
Initial Report FDA Received Date08/28/2019
Supplement Report FDA Received Date12/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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