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

Model Number KNEE SCORPION

Device Problem Difficult to Remove (1528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/20/2020

Event Type  Injury  

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.

Event Description

It was reported that during an arthroscopic knee surgery, the needle was inserted into the device.The needle could not be removed from the device anymore.The surgery was aborted and was not completed successfully.Reason, why surgery was aborted is unknown.Date, when surgery will be repeated is unknown.Update 27-aug-2020: update received that surgery was aborted because loss of fluid into the soft tissue.Another surgery was performed on (b)(6) 2020 and was successfully completed.

Manufacturer Narrative

The related condition could not be determined but the broken needle point condition can be caused by consistently passing the needle through challenging tissue (thick or calcified) or hitting bone.The buckled needle strip condition is typically caused by the device skiving under thick tissue or distorting distally under the jaw.Broken needle point was not removed from distal end of the tip from ar-12990 knee scorpion hand instrument.Remaining portion of the ar-12990n was not returned along with complaint device.

• Brand Name: KNEE SCORPION
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10513485
• MDR Text Key: 206300038
• Report Number: 1220246-2020-02139
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KNEE SCORPION
• Device Catalogue Number: AR-12990
• Device Lot Number: 10584489
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 09/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other