MAUDE Adverse Event Report: ARTHREX INC. ARTHREX SCORPION -MULTI FIRE NEEDLE; NEEDLE, SUTURING, DISPOSABLE

Lot Number 12300015

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/12/2021

Event Type  Injury  

Event Description

When placing the suture with the scorpion needle the surgeon observed that the needle tip broke off of the scorpion needle.The surgeon tried to retrieve the tip of the scorpion needle but was unsuccessful.Fda safety report id# (b)(4).

• Brand Name: ARTHREX SCORPION -MULTI FIRE NEEDLE
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): ARTHREX INC.
• MDR Report Key: 11515205
• MDR Text Key: 241035504
• Report Number: MW5100097
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 12300015
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR