MAUDE Adverse Event Report: ARTHREX, INC. KNEE SCORPION; ACCESSORIES, ARTHROSCOPIC

Model Number KNEE SCORPION

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2020

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 a knee scorpion, ar-12990, was being used in a left side medial meniscal root repair.The surgeon was taking a bite of the medial meniscal root to pass a fiberlink.When he went to fire the needle, the jaw snapped, and the top piece was left in the joint.It was later removed in full, and the case was completed using a second knee scorpion.Additional information requested.Additional information provided 9/14/2020: the broken jaw piece was retrieved using an alligator grasper through an accessory medial incision.This was an additional incision created solely for the purpose to remove the broken jaw.

• Brand Name: KNEE SCORPION
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 10630301
• MDR Text Key: 210002354
• Report Number: 1220246-2020-02202
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867196322
• UDI-Public: 00888867196322
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2020

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: KNEE SCORPION
• Device Catalogue Number: AR-12990
• Device Lot Number: 74829
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other