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

Catalog Number AR-13995N

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/18/2019

Event Type  malfunction  

Event Description

During right shoulder arthroscopy, superior capsular reconstruction, md was using an arthrex multifire scorpion device that contained a disposable needle that passes the suture through the graft.While trying to pass a suture, the scorpion needle broke off and is assumed to be broken off inside the graft tissue.Md decided graft tissue was too thick, and more harm would be caused by searching for it or taking graft apart.An x-ray was performed before closure and was read by a radiologist.Product info: arthrex scorpion-multifire needle ref: ar-13995n, lot number: 10304485, exp: 03/31/2024.Fda safety report id# (b)(4).

• Brand Name: ARTHREX SCORPION-MULTIFIRE NEEDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC. ; naples FL 34108
• MDR Report Key: 8727077
• MDR Text Key: 149079394
• Report Number: MW5087546
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: (01)00888867015951
• 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: 06/19/2019

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: 03/31/2024
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10304485
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2019
• 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: 66 YR
• Patient Weight: 79