MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIOCOMPOSITE SWIVELLOCK C, CLOSED EYELET; FASTENER, FIXATION

Catalog Number AR-2324BCC

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 06/23/2015

Event Type  malfunction  

Event Description

The anchor was inserted through the cannula and when trying to insert the anchor portion, it detached and the suture also detached.All pieces were removed from the shoulder and another anchor was obtained to complete the surgery.

• Brand Name: SUTURE ANCHOR, BIOCOMPOSITE SWIVELLOCK C, CLOSED EYELET
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 5140131
• MDR Text Key: 27981278
• Report Number: 5140131
• Device Sequence Number: 1
• Product Code: MAI
• 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
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: 1279405
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR