MAUDE Adverse Event Report: ARTHREX, INC. DX TRIPLE DAM ARTHROSCOPY CANNULA; ACCESSORIES, ARTHROSCOPIC

Catalog Number AR-6580

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2016

Event Type  malfunction  

Event Description

Patient undergoing an arthroscopic rotator cuff repair and tip of product broke off in the joint.The surgeon was able to retrieve the broken portion.

• Brand Name: DX TRIPLE DAM ARTHROSCOPY CANNULA
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 6360142
• MDR Text Key: 68371824
• Report Number: 6360142
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2016,02/08/2017

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: Physician
• Device Catalogue Number: AR-6580
• Device Lot Number: 623766863
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 61