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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION THIN FLEXIBLE NOZZLE; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION THIN FLEXIBLE NOZZLE; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0606515000
Medical Device Problem Code Delivered as Unsterile Product (1421)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/22/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the sterile package had a hair in it found prior to a case.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the sterile package had a hair in it found prior to a case.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
REVOLUTION THIN FLEXIBLE NOZZLE
Common Device Name
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
MDR Report Key8313166
Report Number0001811755-2019-00493
Device Sequence Number11355528
Product Code JDZ
UDI-Device Identifier34546540447846
UDI-Public34546540447846
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/01/2019
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 Number0606515000
Device Lot Number18223012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Initial Date Received by Manufacturer 01/22/2019
Supplement Date Received by Manufacturer06/27/2019
Initial Report FDA Received Date02/06/2019
Supplement Report FDA Received Date07/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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