MAUDE Adverse Event Report: ARTHREX, INC. RETURNED ANGEL AU, REPAIRED; PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Model Number RETURNED ANGEL AU, REPAIRED

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/27/2022

Event Type  Injury  

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 05/27/2022, it was reported by a sales representative via sems that (2) abs-10060r angel machines are producing error codes.This occurred on (b)(6) 2022, during a harvested bone marrow procedure when the first abs-10060r ((b)(4)) was producing a light sensor error.The second abs-10060r ((b)(4) when turned on its producing an error code disk boot failure - insert system disk.This resulted in the machines not spinning blood down to the proper components.The procedure had to be aborted.

• Brand Name: RETURNED ANGEL AU, REPAIRED
• 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: 14676800
• MDR Text Key: 294131878
• Report Number: 1220246-2022-05092
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00888867249585
• UDI-Public: 00888867249585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK110046
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RETURNED ANGEL AU, REPAIRED
• Device Catalogue Number: ABS-10060R
• Device Lot Number: 11843811
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/27/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other