MAUDE Adverse Event Report: ARTHREX, INC. FASTPASS SCORPION, SL-MF; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number FASTPASS SCORPION, SL-MF

Device Problem Mechanics Altered (2984)

Patient Problem Laceration(s) (1946)

Event Date 04/19/2022

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) 2022, it was reported by a sales representative via sems that an (b)(4) fastpass scorpion had an issue.The surgeon planned to perform an arthroscopic rotator cuff repair on (b)(6) 2022 and ran into an issue when he tried closing the jaws of the scorpion to pass the fibertape through the rotator cuff.The needle would pass through; the jaws just did not close all the way.The top jaws did not fully close, resulting in the suture not being able to capture in the trap door in the scorpion.When the surgeon realized he would not be able to pass the suture with the scorpion through the rotator cuff tissue, he thought he would try the knee scorpion device that they had on the shelf.They do not have the knee scorpion needles separately; therefore, they had to open a meniscal root implant kit.The doctor was not able to get the result he wanted, as he was not able to pass the fibertape through the rotator cuff.Therefore, the doctor decided he would get the best outcome if he opened.There were a few delays in this case because the scorpion did not work.The sales representative supporting this case had to run downstairs to grab the meniscal root repair kit ((b)(4), lot # 13800481) and the surgical team had to open the meniscal repair system tray, this added an additional 20 minutes to the case.The surgeon had to make a large incision to perform an open repair after multiple failed passes, and because the scorpion did not work - it ended up resulting in an additional hour to the case.There was a delay and the patient was under anesthesia longer than they would have been otherwise.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-13999mf scorpion was received for investigation.Functional testing identified that when the finger component was actuated, the jaws at the distal tip were unable to fully close.This failure mode is evaluated further under ncr-19357.

• Brand Name: FASTPASS SCORPION, SL-MF
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14337128
• MDR Text Key: 291380050
• Report Number: 1220246-2022-04881
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867090590
• UDI-Public: 00888867090590
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FASTPASS SCORPION, SL-MF
• Device Catalogue Number: AR-13999MF
• Device Lot Number: 14935708
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other