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

Model Number KNEE SCORPION

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Device has a broken knee scorpion moving jaw.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.The related condition is typically caused by applying excessive force while grasping and manipulating suture and tissue or applying excessive leveraging forces.The mating part (needle) was not returned along with the complaint device.Broken knee scorpion jaw was returned and accounted for during evaluation.

Event Description

It was reported that the jaw does not function.No case involvement reported.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.

Manufacturer Narrative

The related condition is typically caused by applying excessive force while grasping and manipulating suture and tissue or applying excessive leveraging forces.The mating part (needle) was not returned along with the complaint device.Broken knee scorpion jaw was returned and accounted for during evaluation.

• Brand Name: KNEE SCORPION
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11358389
• MDR Text Key: 234403486
• Report Number: 1220246-2021-02626
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867196322
• UDI-Public: 00888867196322
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KNEE SCORPION
• Device Catalogue Number: AR-12990
• Device Lot Number: 11026229
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2021
• Patient Sequence Number: 1