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

Model Number ROB10024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during cori tka xr procedure surgeon initially started on femur bur all, then switched to distal cut.He completed the cuts and punched with the 38mm femoral punch tool.At the end of the procedure, he showed to the rep the lugs.It looks like the 45mm punch tool was used, but it wasn¿t even on the field, it was buried with the tray.At the end of the case rep compared the widths of the punch tunes to see if there was a manufacturing defect and they looked as they should relative to each other.It is suspected to be related to a software-related bug.There was no injury to the patient.The case was completed with cori.Excellent outcome per surgeon.

Manufacturer Narrative

The real intelligence cori, pn: rob10024, sn: sn (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional inspections could not be performed.The software files were downloaded from the device and provided for investigation.The log files do not indicate any system or software issue related to the reported complaint.The reported 38 mm femoral punch was not returned for investigation.The reported complaint could not be confirmed.It should be noted that the tines of the distal punch and the distal cut guide will align.Once the cuts are made and the femur trial is selected, the implant is placed on the bone and the posts are drilled through the lug holes of the implant.These lugs holes are not aligned with the holes created by the tines of the distal punch guide and cut block.This is the likely cause of the reported discrepancy between the femoral lug holes and the 38 mm punch.For guidance on using the distal femur punch and distal cut guide, refer to the ¿performing distal precision burring¿ and ¿using the robotics distal cut guide¿ sections of the real intelligence cori for knee arthroplasty user manual (500230).Per complaint details, after switching from femoral burr-all to distal cut during the cori xr tka, the femoral lug holes ¿looks like the 45mm punch tool was used¿; however only the 38mm punch was in the field.Reportedly, the ¿rep compared the widths of the punch tunes to see if there was a manufacturing defect and they looked as they should relative to each other¿ and communicated that ¿the 38mm punch was not a mislabeled 45mm punch¿.Per correspondence, although extra bone was inadvertently removed, the case was completed ¿up to trialing with cori¿ with ¿excellent outcome¿ per the surgeon and ¿no ill effect to the patient¿.The provided images appear to support the complaint of additional bone removal at the femoral peg holes and appear to have almost a ¿figure 8¿ appearance.The cori user manual instructs to align the placement features of the tka distal punch tool with the burred holes.It was communicated that the requested operative reports/x-rays were not available.The clinical/medical evaluation concluded: ¿based on the information provided, the definitive root cause could not be concluded.The user technique could not be ruled out as a possible contributing factor to the reported event.The assessed patient impact was the additional femoral peg/lug hole bone removal; however, reportedly there was no ill effect on the patient and the surgeon was very satisfied with the excellent outcome.No further medical assessment is warranted at this time.Should further clinically relevant documentation/information become available and/or a product evaluation conclusion results in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.¿ this situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

• Brand Name: REAL INTELLIGENCE CORI
• 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: 11423137
• MDR Text Key: 234977059
• Report Number: 3010266064-2021-00165
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• 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