MAUDE Adverse Event Report: ARTHREX 4.0MM BURR

Catalog Number AR-84000BE

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2016

Event Type  malfunction  

Event Description

Patient underwent shoulder arthroscopy on (b)(6) 2016.During the procedure, metal shavings were released when the burr was used.The equipment was sent back to the manufacturer for evaluation.There was no adverse impact to the patient to date.

• Brand Name: 4.0MM BURR
• Type of Device: BURR
• Manufacturer (Section D): ARTHREX; naples FL 34106
• MDR Report Key: 5917209
• MDR Text Key: 53683197
• Report Number: MW5064437
• Device Sequence Number: 1
• Product Code: HTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AR-84000BE
• Device Lot Number: 10044031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 103