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

Model Number KNEE SCORPION

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2023

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 2/28/2023, it was reported by a facility representative via sems that an ar-12990 knee scorpion had an issue and came apart at the hinges.The sales representative stated it was not due to misuse, the jaw separated inside of the patient.This was discovered during use with no impact on the patient.Additional information has been requested.On 3/2/2023, the sales representative stated the following additional information via phone: this event occurred during a meniscal root repair procedure on (b)(6) 2023.The jaw separated at the hinges inside of the patient, and all fragments were removed.The sales representative was not present at the case but was called by the facility.He offered three solutions to finish the case: to use the suture passing needle as a suture passer, to open and use a regular scorpion-multi fire, or use a suture lasso.One of those methods was used, and the case was completed successfully with no impact on the patient.All parts of the complaint device will be returned for an evaluation, and to obtain a customer letter.No replacement has been requested at this time.

Manufacturer Narrative

Complaint is confirmed.Visual evaluation noticed that the jaw is broken off.The most probable cause is by applying excessive force while grasping and manipulating tissue, or when applying excessive leveraging forces.However, no broken parts were returned for inspection.Functional testing was not performed due to the damage of the device.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: 16582243
• MDR Text Key: 312196513
• Report Number: 1220246-2023-06456
• 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: 10476209
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1