MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI.KNEE TIBIA ADJUSTMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	4240-7500
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a real intelligence cori assisted tka surgery, one (1) stride em tib alignment guide base/arm was placed in the desired location on the tibia.A new 65 mm headless pin was drilled into hole.Then the pin appeared to get stuck and was not seated all the way down.It was tried to pull the pin out, but initially it was not possible.It was needed to increase the force and a different wire driver.Ultimately, it was possible to remove the medial pin first, and then, the lateral pin from the bone.However, the lateral pin was not able to separate from the fixation base once off the bone.A mallet was used to try to separate the pieces.When it was clear that the pin was stuck, the procedure was switched to manual.The pin appeared to be bent into the device.The procedure was completed after a non-significant delay changing to a manual surgical technique.No injuries were reported as a result.
Additional Manufacturer Narrative
H10: after further assessment when the reported device returned, it was noticed that the correct part number was "4240-7500" instead of "pfsr110009".Smith+nephew acts as a the distributor of this product.Enztec ltd, the legal manufacturer was notified of this complaint and is now responsible for performing the regulatory assessment and reporting if required.Corrected data: d1, d2a, d2b, d4 (catalog number, lot number, unique identifier (udi) #).

• Brand Name: RI.KNEE TIBIA ADJUSTMENT
• 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: 21365395
• Report Number: 3010266064-2025-00041
• Device Sequence Number: 12865938
• Product Code: OLO
• UDI-Device Identifier: 09421028118187
• UDI-Public: 9421028118187
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K123380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 4240-7500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/12/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REAL INTELLIGENCE CORI: ROB10024, (B)(6).
• Patient Sex: Unknown