MAUDE Adverse Event Report: ARTHREX MULTIFIRE SCORPION NEEDLE; SUTURE NEEDLE

Model Number AR-13995N

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 11/07/2017

Event Type  Injury  

Event Description

Pt diagnosed with complete tear of right rotator cuff.Pt scheduled for right rotator cuff repair surgery.While suturing the pt post right shoulder surgery, the scorpion needle was noted to break.However, this was retrieved in its entirety without complication.No harm to the pt.Area dressed.The surgeon denies using any excessive force to pass the needle, nor did he meet any resistance.This is a single use disposable item; it is not re-sterilized or reused.

• Brand Name: MULTIFIRE SCORPION NEEDLE
• Type of Device: SUTURE NEEDLE
• Manufacturer (Section D): ARTHREX
• MDR Report Key: 7024662
• MDR Text Key: 91933854
• Report Number: MW5073255
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• 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: 11/08/2017

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 Model Number: AR-13995N
• Device Lot Number: 10133914
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• 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: 62 YR
• Patient Weight: 76