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

Model Number SCORPION-MULTIFIRE NEEDLE

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the tip of the ar-13995n, multifire scorpion needle broke off during a procedure.Additional information received on 03/25/2020: the procedure being performed was an arthroscopic rotator cuff repair.The tip of the ar-13995n broke off when the surgeon fired the needle through the rotator cuff tissue.The fragment was unable to be retrieved.The surgeon did attempt to locate it.No additional incisions were made.A new scorpion needle was opened and the procedure continued.The complaint device will be returning for evaluation.Additional information received on 03/26/2020: per the surgical technologist, the surgeon used a probe to attempt to visualize the fragment on the video screen.

• Brand Name: SCORPION-MULTIFIRE NEEDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 9963778
• MDR Text Key: 187779208
• Report Number: 1220246-2020-01795
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: 00888867015951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10366817
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other