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

Model Number KNEE SCORPION

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 07/30/2020

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 a meniscal root repair case (b)(6) 2020 the surgeon was using an ar-12990 knee scorpion (lot 73360).The knee scorpion would not catch the sutures being passed through the meniscus.The surgeon was able to complete the case using the knee scorpion and a grasper.It took significantly longer than planned and in having to passing the scorpion multiple times more than normal and using a grasper to have to pull the suture through the tissue created some mild fraying in the tissue where they completed the repair.The repair itself still went well and the patient is expected to make a normal recovery.The device will be returned for evaluation.

Manufacturer Narrative

The precise cause for needles not retracting and advancing suture smoothly during function testing could not be determined.The mating part (needle) was not returned along with the complaint device.Used an ar-12990n / lot# 10725473 needle during evaluation.Picture not taken during function test as condition is a function failure not a visual defect.

• Brand Name: KNEE SCORPION
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10441675
• MDR Text Key: 203999746
• Report Number: 1220246-2020-02072
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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: 73360
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 10/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other