MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10015

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 07/21/2020

Event Type  Injury  

Event Description

It was reported that during a cori ukr procedure, after cutting about half of the femur, it was noticed that it was difficult to bur, in exposure mode bur was spinning slow and would not cut, in speed bur, it would not spin and when tried in off mode, it would also not spin.The bur and drill attachment were removed in bur change screen and recalibrated, but the issue was not solved.There was no drill attachment backup.The surgeon finished the rest of the cuts with a saw and checked with cori.This caused a delay of less than 30 minutes.

Manufacturer Narrative

H3, h6: the ri robotic drill attachment, part number rob10015, serial (b)(6) and used for treatment, was not returned for evaluation, however screenshots were provided for review.The screenshots of the patient case do not provide any definitive evidence leading to a root cause of the reported failure, therefore a relationship between the reported event and the device could not be established.A visual/functional inspection could not be completed as no device was returned for evaluation.A historical capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is potentially failing motor assemblies or improper positioning of the burr within drill.The real intelligence cori for knee arthroplasty user manual (500230) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".The reported incident was assessed from a clinical/medical standpoint: the surgeon resorted to manual instrumentation post failure: he finished the rest of the cuts with a saw and checked with cori.This caused a delay of less than 30 minutes.There was no report of harm or impact to the patient nor was any delay reported.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.This failure is an identified failure mode within the risk assessment released during the timeframe of the incident.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 or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• 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, TX 78735 ; 5123913905
• MDR Report Key: 10411817
• MDR Text Key: 203092628
• Report Number: 3010266064-2020-01713
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: ROB20000/CORI ROBOTICS USA/SERIAL: (B)(6)
• Patient Outcome(s): Required Intervention