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 02/20/2023

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 (b)(6) 2023, it was reported by a sales representative via sems that an ar-12990 knee scorpions' top arm broke off.This occurred during a meniscal root repair, and all fragments of the broken device were retrieved.The case was completed using only one suture versus two.There was no additional information provided.Additional information has been requested.

Manufacturer Narrative

Complaint confirmed.Upon visual inspection, it was noted that the top (moving) jaw of the device was broken off.The broken piece was not returned for investigation.The cause of this remains undetermined, however, probable cause can be attributed to prying/leveraging forces being used on the device.

• 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: 16544756
• MDR Text Key: 311416261
• Report Number: 1220246-2023-06419
• 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: 76416
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1