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

Catalog Number	ROB10017
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cori assisted ukr surgery, the tip of the real intelligence point probe was bent when trying to locate the posterior tibial point in the tight uni knee situation.This pointer passed hand piece calibration but when morphing the tibial bone it distorts the 3 d mesh that is mapped and it is completely off the marks.Surgery was resumed after a significant delay with a s+n back-up device.No injuries were reported to the patient.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the real intelligence point probe rob10017, 20fct0048, used during treatment, was returned for evaluation.The reported scenario can be visually confirmed, the tip of the point robe is bent upwards.The reported scenario can be visually confirmed.A functional test was performed.The scenario "when morphing the tibial bone, it distorts the 3d mesh that is mapped and it is completely off the marks" cannot be confirmed.A test case was performed and could be completed without any issues.The 3d mesh could be mapped, all points are in the correct areas, and none of the marks were off.Although the point probe is bent, it functions as intended.The most likely cause for the reported scenario is product mishandling.A review of manufacturing records indicates 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 and the documented risk level is still adequate.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 POINT PROBE
• Common Device Name: 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: 18711151
• Report Number: 3010266064-2024-00029
• Device Sequence Number: 12812263
• Product Code: OLO
• UDI-Device Identifier: 00885556757369
• UDI-Public: 885556757369
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K201022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ROB10017
• Device Lot Number: 22FCT0048
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2024
• Supplement Date Received by Manufacturer: 01/20/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REAL INTELLIGENCE CORI, ROB10024, (B)(6)
• Patient Sex: Unknown