MAUDE Adverse Event Report: ARTHREX, INC SUTURE ANCHOR, PEEK SWIVELLOCK

Catalog Number AR-2324PSLC

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Device Embedded In Tissue or Plaque (3165); Device Embedded In Tissue or Plaque (3165)

Event Date 07/10/2015

Event Type  malfunction  

• Brand Name: SUTURE ANCHOR, PEEK SWIVELLOCK
• Type of Device: SUTURE
• Manufacturer (Section D): ARTHREX, INC; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 4959586
• Report Number: 4959586
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 1425
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2015
• Event Location: Hospital
• Patient Sequence Number: 1
• Patient Age: 60 YR