MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MMX152MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB00031
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a navio tka procedure, when drilling the box, the surgeon hit the femoral bone pin.This damaged the bone pin (bent) making it unusable (it was no longer required either).It did not negatively affect the case (there were no delays and no injuries).No other complications were reported.
Additional Manufacturer Narrative
The navio bone pin, part rob00031, used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, the most likely cause of this event is improper handling of the part.Based on the investigation, no further containment or corrective action is recommended or required 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 BONE PIN 4.0MMX152MM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10680633
• Report Number: 3010266064-2020-01867
• Device Sequence Number: 303786
• Product Code: OLO
• UDI-Device Identifier: 00885556685310
• UDI-Public: 00885556685310
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: ROB00031
• Device Catalogue Number: ROB00031
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1