MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 24 IN. TOUCH SCREEN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10003

Device Problems No Display/Image (1183); Connection Problem (2900)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported that, during set up for a cori assisted tka surgery, the real intelligence 24 in.Touch screen blacked out after registering hand piece.The words ¿no signal¿ came up on the screen and neither the touch screen nor the real intelligence tablet had any signal.The light above the tablet cord port was blinking.They rebooted the real intelligence cori and they could proceed.The procedure was completed with the same devices without significant delays.Since incident occurred before procedure, patient was not involved.

Manufacturer Narrative

Internal reference number: case- (b)(4).

Manufacturer Narrative

H3, h6: the cori touchscreen pn rob10003,sn (b)(6), intended for used in treatment, was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.A review of manufacturing records indicates the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.No reasonable contributing factors could be identified based on the received complaint information and investigation results.The product was not returned and no evidence was made available to link the complaint to an escalation event.In the event of a system failure, refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Smith & nephew has not received adequate materials to fully evaluate the complaint, but if additional relevant materials are later received the complaint can be reopened.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: REAL INTELLIGENCE 24 IN. TOUCH SCREEN
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin; austin, TX 78735 ; 5123913905
• MDR Report Key: 12827919
• MDR Text Key: 280880404
• Report Number: 3010266064-2021-00768
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556756256
• UDI-Public: 00885556756256
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

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: ROB10003
• Device Catalogue Number: ROB10003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1