MAUDE Adverse Event Report: ARTHREX, INC. KNEE SCORPION; MANUAL INSTR, GENERAL SURGICAL

Model Number KNEE SCORPION

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

Patient Problem Insufficient Information (4580)

Event Date 11/09/2023

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 11/09/2023, it was reported by a sales representative via (b)(4) that an ar-12990 knee scorpion snapped.This occurred during a case when the physician was going to make a pass the needle and the suture would not pass.The jaw would not close all the way.

Event Description

Additional information was provided on (b)(6) 2023, where the sales representative reported that this event occurred during a knee arthroscopy with meniscal repair on (b)(6) 2023.The device did not snap off in the patient.Another knee scorpion was brought in, and the case was complete.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-12990 serial/batch 14938062 was received for evaluation.Upon visual evaluation, it was found that the instrument palm spring was disengaged.Functional test was not performed because of the damage.The most likely cause for the reported failure is a manufacturing issue.Ncr-20377 and capa-00377 were opened for this issue.

• Brand Name: KNEE SCORPION
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 18271178
• MDR Text Key: 330675008
• Report Number: 1220246-2023-09193
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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: 14938062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1