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 Fluid/Blood Leak (1250); Output Problem (3005)

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

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

Complaint confirmed, blood was found outside of the consumable, in the angel system bowl.It was found to be contained within the bowl.The disk/bag assembly of the abs-10061t was returned assembled with the angel system.Due to the presence of blood, the device is a biohazard and it could not be evaluated.No abnormalities observed from the picture.The cause of the leak is undetermined.

Event Description

On (b)(6) 2022 it was reported by a sales representative via sems that an abs-10060 angel during a prp spin using an abs-10061t kit broke open and emptied into the machine.The sale rep opened a new kit abs-10063 and retrieved another machine from the distributorship inventory, and a new blood draw was completed.The sales rep started the next spin on the abs-10060r- gb0387 and it wouldn't take up the blood and the screen started glitching.The sales rep tried multiple attempts to remedy with our biologics manager.The prp injection was not completed.

• 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: 13569773
• MDR Text Key: 288689535
• Report Number: 1220246-2022-04501
• 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
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• 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: 1293116551
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1