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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS BLADE, SHAVER, ARTHROSCOPE

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STRYKER SUSTAINABILITY SOLUTIONS BLADE, SHAVER, ARTHROSCOPE Back to Search Results
Model Number 375-544-000
Device Problems Complete Blockage (1094); Dull, Blunt (2407)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2016
Event Type  malfunction  
Event Description
Shaver blades were not sharp enough to cut and were clogging. Surgeon went through five of them. Three were saved and two were discarded.
 
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Type of DeviceBLADE, SHAVER, ARTHROSCOPE
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS
1810 w. drake dr.
tempe AZ 85283
MDR Report Key6010553
MDR Text Key56782694
Report Number6010553
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number375-544-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/07/2016
Event Location Hospital
Date Report to Manufacturer09/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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