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

Model Number SCORPION NEEDLE, KNEE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

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) 2024, it was reported by a sales representative via sems (b)(4) that (2) ar-12990n scorpion needle had breakage during use with no further information provided.The case was completed successfully, with no pieces breaking inside the patient.This was discovered during a root repair procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 2/26/2024: the first needle breakage occurred in the knee, and all fragments were retrieved.The second needle broke inside the shaft of the scorpion while trying to advance the needle, and all fragments were recovered.The fragments were pushed forward to where a little piece came out of the tip, and the tech could grab that tip with a hemostat and pull out.It took 10 minutes to locate the 1st needle fragment, deploy the second needle, and retrieve the 2nd fragment.The case was completed using a shoulder scorpion (ar-13999mf) w/ the appropriate needle (ar-13995n).The compartment was wide enough to work.

• Brand Name: SCORPION NEEDLE, KNEE
• 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: jared engle ; 8009337001
• MDR Report Key: 18878945
• MDR Text Key: 337534170
• Report Number: 1220246-2024-01416
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: 00888867199354
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCORPION NEEDLE, KNEE
• Device Catalogue Number: AR-12990N
• Device Lot Number: 15138174
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1