MAUDE Adverse Event Report: AHTREX; SHAVER 5.5/5.0

Device Problem Metal Shedding Debris (1804)

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

Event Date 02/22/2016

Event Type  malfunction  

Event Description

Metal debris noted and captured in photo while using the arthrex shaver during a shoulder surgery.Metal shavings were noted during use of an arthrex 5.0 and a 5.5 shaver.Photos and device were sent for evaluation.

• Brand Name: AHTREX
• Type of Device: SHAVER 5.5/5.0
• MDR Report Key: 5547780
• MDR Text Key: 42009313
• Report Number: 5547780
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/22/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR