MAUDE Adverse Event Report: ARTREX, INC. ARTHREX SCORPION SUTURE PASSER

Model Number AR-13997SF

Device Problem Cut In Material (2454)

Patient Problem No Information (3190)

Event Date 08/24/2016

Event Type  Injury  

Event Description

During arthroscopic shoulder repair, arthrex scorpion suture passer cut suture as it was passed through.Equipment removed and saved.Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by calling my number.

• Brand Name: ARTHREX SCORPION SUTURE PASSER
• Type of Device: SUTURE PASSER
• Manufacturer (Section D): ARTREX, INC. ; 1370 creekside blvd.; naples FL 34108 1945
• MDR Report Key: 5955866
• MDR Text Key: 55110565
• Report Number: MW5064804
• Device Sequence Number: 1
• Product Code: HWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-13997SF
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention
• Patient Age: 53 YR