MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX SUTURE ANCHOR/SUTURE TAK; ARTHREX SUTURE ANCHOR/BIOCOMPOSITE SUTURE TAK

Model Number AR-8934BCNF

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

Patient Problem No Code Available (3191)

Event Date 05/14/2014

Event Type  malfunction  

Event Description

Tip of suture tak inserter broke off in the patient during implantation of anchor into the patient's foot.

• Brand Name: ARTHREX SUTURE ANCHOR/SUTURE TAK
• Type of Device: ARTHREX SUTURE ANCHOR/BIOCOMPOSITE SUTURE TAK
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• MDR Report Key: 3889984
• MDR Text Key: 17618282
• Report Number: 3889984
• Device Sequence Number: 1
• Product Code: MAI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AR-8934BCNF
• Device Lot Number: 1192128
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2014
• Patient Sequence Number: 1
• Patient Age: 16 YR