MAUDE Adverse Event Report: ARTHREX SCORPION NEEDLE

Catalog Number AR-8690DS

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Test Result (2695); Device Embedded In Tissue or Plaque (3165)

Event Date 01/07/2016

Event Type  malfunction  

Event Description

During the procedure a portion of the scorpion needle broke in the wound.Physician was unable to retrieve.An xray was taken and the needle portion identified.Physician stated he could not retrieve and stated he would bring the patient back at a later date if the object "bothered the patient".Noted the ref lot and exp.Remaining portion of the disposable instrument was disposed of in sharps bin.

• Brand Name: SCORPION NEEDLE
• Type of Device: SCORPION NEEDLE
• Manufacturer (Section D): ARTHREX; naples FL 34108
• MDR Report Key: 5394128
• MDR Text Key: 36970923
• Report Number: MW5059668
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: AR-8690DS
• Device Lot Number: 600120
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 83