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

Model Number KNEE SCORPION

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2023

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 11/10/2023, it was reported by a sales representative via (b)(4) that an ar-12990 knee scorpion broke.This occurred during a case.There was no additional information provided, and additional information has been requested.

Manufacturer Narrative

Complaint is confirmed.Functional testing was not performed on the returned ar-12990 due to the damage to the device.Visual inspection noted the moving jaw of the device is broken off and was not returned.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during firing of the needle and/or unsecure grasp of tissue.Refer to the investigation photo.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18271209
• MDR Text Key: 329807518
• Report Number: 1220246-2023-09196
• Device Sequence Number: 1
• Product Code: NBH
• 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: 02/01/2024

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: 69568
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1