MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10013

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  Injury  

Event Description

It was reported that during a cori tka procedure, the first robotic drill could not seat the bur in the carriage.They swapped to another robotic drill that did not seem to mill as it should, even though they did not receive any errors.It did not appear to be cutting bone efficiently.The bone was very hard and the surgeon moved between making saw cuts and cleaning up cuts with bur, but it did not appear to cut much.There was a change to manual procedure and a delay greater than 30 minutes.No other complications have been reported.

Manufacturer Narrative

H3, h6: the cori drill, p/n rob10013 sn (b)(6), used in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A relationship between the reported event and the device was not established.A functional evaluation was performed and the reported problem was not confirmed.The drill functioned as expected without any connection issues.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Ensure the bur is not overloaded when cutting.This situation is captured in the cori risk assessment released at the time of the complaint.Although the reported problem was not confirmed, a potential contributing factor could be improper method of engaging cori drill attachment to the robotic drill.Refer to the cori user¿s manual for proper handling and troubleshooting of the drill.Based on the investigation, no further containment or corrective action is recommended or required at this time.

Manufacturer Narrative

H3,h6: the cori drill, p/n rob10013 (b)(6), used in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A relationship between the reported event and the device was not established.A functional evaluation was performed and the reported problem was not confirmed.A capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The drill functioned as expected without any connection issues.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Ensure the bur is not overloaded when cutting.This situation is captured in the cori risk assessment released at the time of the complaint.Although the reported problem was not confirmed, a potential contributing factor could be improper method of engaging cori drill attachment to the robotic drill.Refer to the cori user¿s manual for proper handling and troubleshooting of the drill.Based on the investigation, no further containment or corrective action is recommended or required at this time.

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL
• 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: rick confer ; 2828 liberty avenue; suite 100, PA 15222
• MDR Report Key: 10514153
• MDR Text Key: 206312267
• Report Number: 3010266064-2020-01754
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention