MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CHECKPOINT PINS QTY:4; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	ROB10012
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a cori assisted surgery using hip7 navigation performed on (b)(6)2025, it was noticed through an x-ray that a real intelligence checkpoint pins qty:4 was left in femur.The patient was brought back to theatre and a revision surgery was performed on (b)(6)2025 to remove it.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the real intelligence checkpoint pins qty:4, part number rob10012, lot number unknown, used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.The clinical/medical investigation concluded that the adverse event was likely procedure related, and the device had no influence on the event.As the real intelligence cori for knee arthroplasty user manual 500230, rev g, does warn; ¿remove all checkpoint pins prior to closing the incision.When removing the checkpoint pins, avoid wrenching the pin out of the bone.Be sure to pull perpendicularly away from the patient¿s bone to avoid breaking off the head of the pin.¿ a complaint history review was performed by part number, and no similar complaints were identified.Without definitive lot number a complaint history review cannot be performed for the lot number involved.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event was procedure related.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.

• Brand Name: REAL INTELLIGENCE CHECKPOINT PINS QTY:4
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23291352
• Report Number: 3010266064-2025-00225
• Device Sequence Number: 4863899
• Product Code: OLO
• UDI-Device Identifier: 00885556757314
• UDI-Public: 885556757314
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ROB10012
• Device Lot Number: UNKNOWN
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female