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

Model Number KNEE SCORPION

Device Problems Use of Device Problem (1670); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported by the sales rep: during a medial root repair case; after he prepared his tunnel and passed /retrieved the fiberstick, the surgeon tried passing the fiberlink through the medial meniscus, using the correct technique with the knee scorpion.He was unsuccessful in his first 2-3 times passing with the scorpion; therefore, the rep had him check and see if the needle would fire outside the knee without any suture in it (it correctly fired).Following, rep had him load in the suture and fire the needle outside the knee without squeezing the trigger, which preloaded the suture in the needle.Then he tried firing the scorpion within the knee and again, was unsuccessful.Rep then made sure he was squeezing the trigger and firing the needle at the same time and he did so for another 2-3 tries and was unsuccessful.The needle was removed and a new one was loaded ¿ as well as a new fiberlink suture.Rep then instructed him to try grabbing a smaller bite and again, was unsuccessful 3-4 more times.Rep then asked if they could move the camera to watch the needle fire because it was successfully firing outside the knee.They watched the needle fire 5-6 times in the knee and 3 of the times, they could see the suture passing through meniscus but then not catching in the roof of the scorpion and as surgeon would release his palm and trigger, the suture would fall with it.The other times, they saw the needle fire and no suture was moving through the meniscus.After the 5-6th time of watching the needle fire and not catching in the hood, surgeon asked for ceterix and used that to pass through the meniscus.Then, he finished the case using an arthrex fiberstick passer, button and backup fixation with swivelock.In total, surgeon tried passing with the scorpion 13+ times.Needles used were one from an ar-4550 kit (batch 10229400) and one from batch 10175441.Follow-up regarding change in incision: in explanation of the incision - during surgeon's failed attempts to pass the scorpion he removed his passing suture (fiberstick) to get better visualization.Therefore, after he successfully passed through the meniscus with ceterix he struggled to find his tunnel in the tibia.He tried using the suture passing needle with nitinol wire but it got clogged with bone particles and he was unable to pass the nitinol wire through, even after using a spinal needle¿s stylet to try and unclog.So he went back in the tibia with a 2.4 pin then the flipcutter.Since he went over his previous tunnel, the hole was a little larger and he was worried the button wouldn¿t hold; therefore, he used the acl backup kit with the 4.75 swivelock.With the backup, he made a larger incision.Therefore, there was not necessarily an additional incision made; however, a larger incision was made than he was previously planning.

Manufacturer Narrative

The complaint was not confirmed.The evaluation did not reveal anything relevant to the event.The mating parts (needles) used during the event were not returned.Used an ar-12990n/lot#10175441 needle during evaluation.

• Brand Name: KNEE SCORPION
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 8054651
• MDR Text Key: 126914501
• Report Number: 1220246-2018-00733
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

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: 87105C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other