MAUDE Adverse Event Report: ARTHREX, INC. CDC MEDICAL, LLC /ARTHREX; ARTHREX SCORPION NEEDLE

Model Number AR-16991N

Device Problems Difficult or Delayed Positioning (1157); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2016

Event Type  malfunction  

Event Description

During hip arthroscopy with labral tear using cinch stitch and pushlocks, after an unsuccessful pass it was fired quickly.Physician discovered some resistance and then heard a loud click.Upon inspection of device and needle tip, it was suspected to be broken at the groove tip.Upon inspection of the joint, it was not determined to be located under arthroscopic visualization or after multiple fluoroscopy shots.

• Brand Name: CDC MEDICAL, LLC /ARTHREX
• Type of Device: ARTHREX SCORPION NEEDLE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 6050172
• MDR Text Key: 58171236
• Report Number: MW5065546
• Device Sequence Number: 1
• Product Code: MDM
• 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: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: AR-16991N
• Device Lot Number: 10038104
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR