MAUDE Adverse Event Report: ARTHREX, INC. SCORPION-MULTIFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number AR-13995N

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

Patient Problem Foreign Body In Patient (2687)

Event Date 01/15/2020

Event Type  malfunction  

Event Description

During the right shoulder arthroscopic rotator cuff repair, the tip of the scorpion needle broke off.Removing the tip might cause more damage to the rotator cuff tendon so it was safer to leave it than remove it.X-ray confirmed the tip.

• Brand Name: SCORPION-MULTIFIRE NEEDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC. ; naples FL
• MDR Report Key: 9627103
• MDR Text Key: 176420592
• Report Number: MW5092464
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• 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: 01/17/2020

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 Catalogue Number: 149850
• Device Lot Number: 10404639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2020
• 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: 54 YR
• Patient Weight: 89