MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS / INCISOR; SAW, POWERED, AND ACCESSORIES

Model Number	7205332
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During a knee arthroscopy while using a shaver blade it was noted the inner cannula shaving teeth was not circulating/spinning like usual and making a squeaky nose.Doctor handed shaver to scrub tech.At back table, scrub tech noted the inner cannula came right out and inner cannula's tip broke off and remained stuck inside the outer shaver cannula.Both cannulas removed from field and new shaver, same size, opened without problems.

• Brand Name: DYONICS / INCISOR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7135 goodlett farms pkwy; cordova TN 38016
• MDR Report Key: 8900870
• Report Number: 8900870
• Device Sequence Number: 16638797
• Product Code: HAB
• UDI-Device Identifier: 03596010251602
• UDI-Public: (01)03596010251602
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/25/2019
• Report Date (Section F): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7205332
• Device Catalogue Number: 7205332
• Device Lot Number: 50741464
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/25/2019