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

Model Number 7205332

Device Problems Break (1069); Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

Event 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
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7135 goodlett farms pkwy; cordova TN 38016
• MDR Report Key: 8900870
• MDR Text Key: 154548751
• Report Number: 8900870
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251602
• UDI-Public: (01)03596010251602
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205332
• Device Catalogue Number: 7205332
• Device Lot Number: 50741464
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2019
• Type of Device Usage: N
• Patient Sequence Number: 1