MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ANGEL PRP KIT (US TRAY); PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Model Number ARTHREX ANGEL PRP KIT (US TRAY)

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/08/2023

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 3/9/2023, it was reported by a sales representative via email that the port where the tubing runs down to the separation latter on an abs-10061t arthrex angel prp kit leaked blood, and it splattered all over the centrifuge and onto the surrounding surfaces.This was discovered during a procedure on (b)(6).Additional information requested.

Manufacturer Narrative

Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure is a supplier manufacturing issue addressed on ncr-22300.

Event Description

Additional information received on 4/10/2023: this was discovered during a prp injection; the patient was not under anesthesia.The case was completed with another abs-10061t arthrex angel prp kit and angel centrifuge.Additional information received on 4/10/2023: the blood leaked out of the centrifuge, and the sales representative came in contact with it while removing the machine and cleaning the blood off of it.

• Brand Name: ARTHREX ANGEL PRP KIT (US TRAY)
• Type of Device: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• 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: 16617777
• MDR Text Key: 312017391
• Report Number: 1220246-2023-06488
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00888867279919
• UDI-Public: 00888867279919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK180180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/09/2024

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: ARTHREX ANGEL PRP KIT (US TRAY)
• Device Catalogue Number: ABS-10061T
• Device Lot Number: 2346127512
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 08/19/2024
• Supplement Dates FDA Received: 09/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1