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

Model Number KNEE SCORPION

Device Problems Break (1069); Entrapment of Device (1212); Mechanical Jam (2983)

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

Event Date 12/27/2019

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 meniscus root repair procedure, the needle contained inside of the meniscal root kit, ar-4550, jammed up and broke inside of the knee scorpion, ar-12990.The needle was unable to become disengaged from the scorpion and the procedure was completed by performing a partial meniscectomy.Additional information provided 01/07/2020: the needle will be returned with the scorpion as it is still lodged within the device.No additional incision was needed to complete the partial menisectomy.There were no fragments of the needle retained in the patient and the rest of the needle was disposed.

Manufacturer Narrative

The evaluation did not reveal anything relevant to the event.The mating part (needle) that belongs to the meniscal root kit ar-4550 (ar-12990n/unknown lot number) was not returned nor broken inside the ar-12990 knee scorpion hand instrument.Used an ar-12990n/lot#: 10160987 needle during evaluation.Picture attached in the complaint to demonstrate no broken needle was found inside the tip.

• Brand Name: KNEE SCORPION
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9631358
• MDR Text Key: 190113219
• Report Number: 1220246-2020-01602
• 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: 02/11/2020

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: 80944
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 02/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other