MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX MULTIFIRE SCORPION NEEDLE

Model Number AR-13995N

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

During the shoulder procedure while using the scorpion needle the tip of the needle broke off in the pt and lodged in the soft tissue.An x-ray was obtained of the area, surgeon was unable to retrieve the piece of the needle.Diagnosis or reason for use: left shoulder rotator cuff tear after prior repair.

• Brand Name: ARTHREX MULTIFIRE SCORPION NEEDLE
• Type of Device: SCORPION NEEDLE
• Manufacturer (Section D): ARTHREX, INC.; naples FL 34108
• MDR Report Key: 4627567
• MDR Text Key: 17580082
• Report Number: MW5041582
• Device Sequence Number: 1
• Product Code: NBH
• 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: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: AR-13995N
• Device Lot Number: 1428628Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR