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

Catalog Number	4240-7502
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cori assisted tka surgery; after prepping the femur the surgeon went to navigate the tibia cut.While he was trying to raise the adjustable tibia guide, they turned the knob to the wrong direction.They bottomed out the adjustable tibia guide and kept twisting the knob to the left until the knob broke off.Now the adjustable tibia guide and the fixation base are stuck together because the knob broke off.The case was completed robotically, but the surgeon ended up burring the whole tibia cut instead of navigating the cut with the plane visualizer.The procedure was performed, after a significant delay, using a s+n back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or 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 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 conservatively 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.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Smith+nephew is the distributor of this product.Enztec ltd, the legal manufacturer, is responsible for performing the regulatory assessment and reporting to any nca if required.

• Brand Name: RI.KNEE TIBIA FIXATION BASE RIGHT
• 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: 20808921
• Report Number: 3010266064-2024-00236
• Device Sequence Number: 9806951
• Product Code: OLO
• UDI-Device Identifier: 09421028118200
• UDI-Public: 9421028118200
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 01/07/2025

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
• Device Catalogue Number: 4240-7502
• Device Lot Number: 241359
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2024
• 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: 4240-7500 / LOT # UNKNOWN.; ROB10024 / SERIAL # (B)(6).
• Patient Sex: Unknown