MAUDE Adverse Event Report: ARTHREX, INC. SCORPION NEEDLE, KNEE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number SCORPION NEEDLE, KNEE

Device Problems Break (1069); Complete Blockage (1094); Failure to Advance (2524)

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

Event Date 04/27/2022

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

It was reported that the needle can´t go through the product.It was noticed before the surgery.There was no harm for patient, operator or third party.Update (b)(6) 2022: the device is clogged.Update (b)(6) 2022: the needle had broken due to a poorly chosen thread.They used the wrong thread size fiberwire® #2.This was noticed during surgery.There was no harm for patient, operator or third-party.The surgery was finished successfully with a labral scorpion.The needle broke off inside the patient, but it was retrieved.A second surgery was not necessary.

• Brand Name: SCORPION NEEDLE, KNEE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14470101
• MDR Text Key: 300393717
• Report Number: 1220246-2022-04968
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867266520
• UDI-Public: 00888867266520
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2022

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 Expiration Date: 07/31/2024
• Device Model Number: SCORPION NEEDLE, KNEE
• Device Catalogue Number: AR-12990N-1
• Device Lot Number: 10352182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/23/2022
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1