MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number AR-8400CDS

Device Problem Material Fragmentation (1261)

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

Event Date 07/06/2020

Event Type  malfunction  

Event Description

Surgeon went to shave in the joint space with the curved dissector.As the shaver was turned on, metal shavings began floating in the joint space.The shaver was removed.Metal shavings were suctioned out of the joint.Surgeon stated there were not remaining metal shavings to be found.

• Brand Name: ARTHREX
• Type of Device: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 6875 arthrex commerce drive; ave maria FL 34142
• MDR Report Key: 10487430
• MDR Text Key: 205480360
• Report Number: 10487430
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AR-8400CDS
• Device Catalogue Number: AR-8400CDS
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5110 DA