MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO TKA FEMUR DISTAL CUT GDE MED; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB00006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the femur cutting stage of a navio tka procedure, it was found that the femur distal cut guide was damaged, its screw was broken.It was broken when placing on the patient's bone, however, all the broken pieces fell on the operating table.They continued with the another femur tka cut guide from another tray without delay.No other complications were reported.
Additional Manufacturer Narrative
The navio tka femur distal cut guide medium, rob00006 used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.While all products meet required manufacturing specifications prior to release, a serial number is required to complete a manufacturing dhr review.A complaint history review for similar reported/confirmed complaints has identified no prior events.Although the reported problem was not confirmed, a contributing factor may be a broken part.No containment or corrective actions are recommended at this time.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO TKA FEMUR DISTAL CUT GDE MED
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11327844
• Report Number: 3010266064-2021-00107
• Device Sequence Number: 10983686
• Product Code: OLO
• UDI-Device Identifier: 00885556685082
• UDI-Public: 00885556685082
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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 Model Number: ROB00006
• Device Catalogue Number: ROB00006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1