MAUDE Adverse Event Report: ARTHREX ARTHREX; MULTI-FIRE SCORPION NEEDLE

Model Number AR-13995N

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/17/2016

Event Type  malfunction  

Event Description

Tip of scorpion needle broke off in patient's tissues.A piece of the needle was noted and removed but the remainder of the needle could not be located.An x-ray showed the piece of metal still in patient but it could not be visualized.Surgeon visualized glenohumeral joint and noted that the metal piece is not noted in joint.

• Brand Name: ARTHREX
• Type of Device: MULTI-FIRE SCORPION NEEDLE
• Manufacturer (Section D): ARTHREX; 1803 grandstand dr; san antonio TX 78238
• MDR Report Key: 5573329
• MDR Text Key: 42645177
• Report Number: MW5061642
• Device Sequence Number: 1
• Product Code: HRX
• 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: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-13995N
• Device Catalogue Number: AR-13995N
• Device Lot Number: 14346232
• Was Device Available for Evaluation?: No
• 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 Age: 62 YR
• Patient Weight: 86