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 Problems Leak/Splash (1354); Output Problem (3005)

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

Event Date 07/27/2022

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

On (b)(6) 2022 it was reported by a sales representative via sems that an abs-10061t prp kit had an issue with the tubing during a prp injection.The tubing that wraps around the rotating pump rotor caused blood to pool where the light sensor is.No patient affect.Additional information 8/3/2023: the blood actually leaked from the tubing to the outside of the unit and pooled where the light sensor is.The angel centrifuge and the kit was replaced and the procedure was completed with no further issues.No patient harm.

Manufacturer Narrative

Complaint confirmed.Visual evaluation of the picture of a device that looks like an abs-10060- angle centrifuge attached to the complaint.It is inferred that the tube wrapping around the rotating pump rotor had a hole causing the blood leaking.The probable cause of the event could not be determined from the information available and without device evaluation.

• 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: 15224056
• MDR Text Key: 304124349
• Report Number: 1220246-2022-05374
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: ARTHREX ANGEL PRP KIT (US TRAY)
• Device Catalogue Number: ABS-10061T
• Device Lot Number: 2158122594
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1