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	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 has been updated.
Event or Problem Description
It was reported that while setting up for a cori assisted tka surgery, the real intelligence point probe fell to the ground and its tip got bent.The procedure was performed, after no delay, with manual technique.Since incident occurred before procedure; patient was not yet involved.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
Section d10 was updated.Section h10: the real intelligence point probe, part number rob10017, lot number 20fct0029, intended for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with product mishandling.Based on the investigation, no containment or corrective action is recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number:(b)(4).Section d4 was corrected.

• 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: 19556466
• Report Number: 3010266064-2024-00135
• Device Sequence Number: 6711216
• Product Code: OLO
• UDI-Device Identifier: 00885556757369
• UDI-Public: 885556757369
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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
• Device Catalogue Number: ROB10017
• Device Lot Number: 20FCT0029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: Not provided; 06/26/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 06/18/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REAL INTELLIGENCE CORI / ROB10024; RI CORI (PN: ROB10024/ SN: (B)(6))
• Patient Sex: Unknown