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

Model Number KNEE SCORPION

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 11/16/2023

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 11/16/2023, it was reported by a sales representative via (b)(4) that an ar-12990 knee scorpion already had a broken needle inside of it.They tried to put a new needle in and it would not go in.It was stated that it is unknown when the broken needle inside the ar-12990 knee scorpion happened, but it was noticed on 11/16/2023 when loading a needle into the device.The case was completed using a non-arthrex suture passer instead without any adverse effects on the patient.There was a 3-5 minute delay in the procedure.This was discovered when loading a needle into the ar-12990 knee scorpion during an meniscus repair procedure on (b)(6) 2023.

• 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: 18340963
• MDR Text Key: 331061051
• Report Number: 1220246-2023-09457
• 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
• Report Date: 12/15/2023

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: 10237225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1