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

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.

• Type of Device: BLADE, SHAVER, ARTHROSCOPE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 6010553
• MDR Text Key: 56782694
• Report Number: 6010553
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 375-544-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1