MAUDE Adverse Event Report: ARTHREX, INC. KNEE SCORPION; MANUAL INSTR, GENERAL SURGICAL

Model Number KNEE SCORPION

Device Problem Break (1069)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  malfunction  

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 3/3/2023, it was reported by a sales representative via sems that an ar-12990 knee scorpion had an issue.The top jaw snapped off but was retrieved during the case.They could not use the knee scorpion to continue the case, so the surgeon used another handpiece to complete the procedure.No adverse event or patient harm due to the breakage of the hand instrument.This was discovered during use with no impact on the patient.Additional information has been requested.On 3/7/2023, the sales representative provided the following information via phone: this event occurred during a knee scope, a meniscal root repair procedure on 3/3/2023.The patient's knee was very tight.When passing the suture through the meniscal root, when the surgeon fired, the top jaw broke off at the hinges inside of the patient.All fragments were retrieved, and a competitor's product was used to complete the procedure successfully with no impact on the patient.

Manufacturer Narrative

Complaint is confirmed.Upon visual evaluation noticed that the jaw is broken off.This is typically caused by applying excessive force while grasping and manipulating tissue, or when applying excessive leveraging forces.No broken parts were returned for investigation.The cause remains undetermined.

• Brand Name: KNEE SCORPION
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• 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: 16597201
• MDR Text Key: 312196655
• Report Number: 1220246-2023-06473
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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 Model Number: KNEE SCORPION
• Device Catalogue Number: AR-12990
• Device Lot Number: 10228640
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1