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 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device broke during the first use.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.Update nro 06-feb-2024: further information revealed that during a knee arthroscopy the suture of the disposable applicator tore inside of the patient.The broken pieces were retrieved from patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new scorpion.It was not necessary to switch the surgical technique or do a second surgery.Update pgail 27-feb-2024 two additional needles were received with the initial reported knee scorpion.Update pgail 13-mar-2024 during the incoming inspection it was noticed that the tip of one needle is broken off.Further questions will be asked.

• 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: 18904797
• MDR Text Key: 337697826
• Report Number: 1220246-2024-01467
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867199354
• UDI-Public: 00888867199354
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 15144741
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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