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

Model Number KNEE SCORPION

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2021

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) 2021, it was reported by a sales representative via sems that an ar-12990 knee scorpion needle got stuck and broke off.This was discovered during a procedure, no further details given.Additional information received 10/1/2021 while doing a meniscus repair, upon firing through a scarred posterior medial meniscus, the needle inside the knee scorpion snapped.The needle is still broken inside and was not able to be removed from scorpion device.All broken fragments were retrieved from patient and surgeon completed case successfully by tying a labral scorpion and a suturelasso.

Manufacturer Narrative

Complaint could not be confirmed.Visual evaluation identified signs of use but no device malfunction.Additionally, the associated needle was not returned with the device and therefore could not confirm the reported event.

• Brand Name: KNEE SCORPION
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12659626
• MDR Text Key: 279816523
• Report Number: 1220246-2021-03816
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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: 12922563
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/26/2021
• Patient Sequence Number: 1