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

Catalog Number AR-13995N

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2017

Event Type  malfunction  

Event Description

During shoulder arthroscopy procedure, a multifire scorpion needle tip broke off in pt.The piece was left in place.

• Brand Name: ARTHREX: SCORPION MULTIFIRE NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): ARTHREX, INC.; naples FL 34108
• MDR Report Key: 6380904
• MDR Text Key: 69262593
• Report Number: MW5068283
• Device Sequence Number: 1
• Product Code: GAB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10018862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR