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

Model Number KNEE SCORPION

Device Problems Break (1069); Noise, Audible (3273)

Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

The complaint was confirmed.The related condition is typically caused by applying excessive force while grasping and manipulating suture and tissue or applying excessive leveraging forces.Knee scorpion jaw was returned along with complaint device.Confirmed component to be within hardness specification.Standard function test could not be performed due to the related condition.

Event Description

It was reported that during a meniscus repair procedure, the knee scorpion ar-12990, broke.The surgeon passed the device into the joint, positioned it under the meniscus to fire the needle and a loud audible click was heard.Once the surgeon backed the device up, it was noticed that the entire top jaw had broken off of the instrument.The needle was still in tact and the suture was removed from the joint but staff had to explore the knee (arthroscopically) to fish out the free floating top jaw of the knee scorpion.The surgeon was not able to "potentially" repair the meniscus.Instead, the surgeon debrided the meniscus where it was torn.

• 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: 9353245
• MDR Text Key: 167338083
• Report Number: 1220246-2019-01424
• 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: 11/21/2019

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: 72375
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other