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

Model Number ROB10015

Device Problem Unintended Movement (3026)

Patient Problems Injury (2348); Deformity/ Disfigurement (2360)

Event Date 09/10/2020

Event Type  Injury  

Event Description

It was reported that, during a cori procedure, they used both the side and the end of the bur in speed control to refine the surface of the bone.There was a discrepancy visible on the order of 1 to 2 mm between the bone surface refined with the side of the bur relative to the registered position of the tip of the bur.(when he placed the tip of the bur on the bone surface where he'd just refined, the tip hovered over the refined surface by 1-2mm.The pointer probe was used to check the surface, and the pointer probe tip agreed with the handpiece tip location.The doctor used a saw to cut most of the medial side of the joint, and did not seem to finish the lateral side.The plate probe was used to verify the cut, which registered a 2 degree varus cut relative to plan, which would be consistent with the final coloring of the surface.This also tends to agree with the final registered leg alignment, which was 6 degrees, as opposed to a planned 3 degrees of varus.The doctor stated that the 6 degree reported alignment "looks like 3 degrees").It was difficult to know how much of the "red" on the medial condyle was a contributor to the varus cut error, or if it was simply a "virtual overcut".The robotic drill/handpiece, tacker and long attachment used in this case could also be bent or loose, which could have contributed to the event.The troubleshooting of the shaving discrepancy added 5 to 10 minutes of delay.No other complications were reported.

Manufacturer Narrative

H3, h6: the ri robotic drill attachment (us) rob10015, s/n sn (b)(6) used for treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.A kpc test was performed and the test passed.A case run and the drill attachment functioned as intended without any issues.The drill attachment fits tight on the drill and the shaft and bearings work correctly.Although the reported problem was not confirmed a factor that may have contributed to the reported symptom may have been associated with improper assembly/disassembly.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 concluded this was an isolated event.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.Care and caution should be exercised during the surgical site setup and tear down to protect the device from an unforeseen force, such as falling onto a hard surface or damage.Refer to the real intelligence cori for knee arthroplasty for proper handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details, ¿there was a discrepancy visible on the order of 1 to 2 mm between the bone surface refined with the side of the bur relative to the registered position of the tip of the bur¿.Reportedly, a final mal-alignment ¿was 6 degrees, as opposed to a planned 3 degrees of varus¿; however, ¿the doctor stated that the 6 degree reported alignment "looks like 3 degrees".Per correspondence, the requested op notes and imaging would not be accessible for inclusion in the medical investigation.Based on the information provided the impact beyond the reported ¿varus cut error¿ and a 5-10 minute surgical delay could not be definitively determined; although, it was communicated that there was no additional interventions required and surgeon was ultimately satisfied with the surgical outcome.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.

• 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; suite 100; austin, TX 78735 ; 5123913905
• MDR Report Key: 10652773
• MDR Text Key: 210592184
• Report Number: 3010266064-2020-01825
• 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: K191223
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• 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
• Treatment: ROB20000/CORI ROBOTICS USA
• Patient Outcome(s): Other