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

Catalog Number ROB10013

Device Problems Connection Problem (2900); Material Split, Cut or Torn (4008)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a cori-assisted tka, when the real intelligence robotic drill was being calibrated it did pass the calibration stage.This was tried at least three times.It was received a "system time out: the robotic drill has bee deactivated".Diagnostic test was performed with failed result.Surgery was performed after a non-significant delay, with manual instrumentation.No patient complications were reported.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part # rob10013, serial #: (b)(6), intended for use in treatment, was returned for evaluation.No system log files or screenshots were provided for investigation, as such a thorough investigation could not be performed.Should screenshots or system log files become available, the case can be reopened.The cable strain relief at the handpiece handle has separated from the metal and the internal wiring is exposed.There is residue of adhesive around the handle and on the strain relief, seeming that some tape was used to secure the strain relief in place.A functional evaluation was performed.The reported problem was not confirmed.Drill was found to function normally despite the cable damage.No errors were observed during testing.An additional investigation was performed.The reported problem was confirmed.Review of the provided photos confirmed that a system time out error was received, the drill's strain relief was separated with exposed wiring, and the drill failed kpc testing on the set maximum speed check.These two errors could not have been caused by the same fault, as the set maximum speed check is related to the drill motor, whereas the system time out failure is often related to the exposure motor.Although the reported errors could not be reproduced during testing, the failures were confirmed from the provided photos.The most likely cause for the cable sleeve separation from the handpiece seems to be that the sleeve's bond was worn down over time due to fatigue.Possible causes for the system time out error may have been related to the exposed wiring in the cable being twisted or pinched, or that there may have been an intermittent failure with the exposure motor.Since the exposure checks of the kpc passed, it can be assumed that this was only a temporary error and not an indication of a permanent failure in the device.The failure observed during the kpc test seems completely unrelated to the system time out error observed.It is possible that the orange pedal was not being held during that stage of drill testing, or due to a fault in the foot pedal used.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 found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file including a documented risk level.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18426900
• MDR Text Key: 331878245
• Report Number: 3010266064-2024-00001
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• 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: Unknown
• Patient Sequence Number: 1