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

Model Number KNEE SCORPION

Device Problem Defective Device (2588)

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

Event Date 03/05/2024

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.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

On 8th march 2024, it was reported by a sales representative via email that an ar-12990n-1, scorpion needle, knee broke within knee scorpion.The first knee scorpion needle broke off during use inside of the knee scorpion handle.The second needle was opened in an attempt to fix the situation and push the broken part out of the shaft of the instrument unfortunately the broken piece was wedged very tightly in the shaft of the instrument and was unable to be removed.They did not have a backup instrument, and unfortunately neither needle was able to be used.This was detected on 5th march 2024 during a knee arthroscopy, posterior root repair of medial meniscus procedure.Procedure was completed successfully with no patient harm as a labral scorpion and surefire needle was used instead.12 march 2024 - the sales rep.Responded that an ar-12990, knee scorpion¿ was also defective due to the original needle breaking off inside it.

• 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: jared engle ; 8009337001
• MDR Report Key: 18915860
• MDR Text Key: 337808461
• Report Number: 1220246-2024-01514
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867196322
• UDI-Public: 00888867196322
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/15/2024

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1