MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE TRACKER ARRAY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR120010

Device Problem Calibration Problem (2890)

Patient Problem Injury (2348)

Event Date 10/16/2019

Event Type  Injury  

Event Description

It was reported that after surgeon burred distal femur, he burred holes for femoral 4 in one cutting block.He then put the cutting block spikes into the burred holes and used the visualization tool to navigate cutting block.When the block was centered in the burr holes the cut was proud by about 10mm.The surgeon then navigated the block approx 10mm posterior from the burr holes and it indicated it was right on plan.So the burr holes were not in correct spot but approximately 10mm anterior.Noted that during initial burring of distal femur is was notice that the tracker arrays were very loose on the handpiece and would not let surgeon burr.Once tightened he was able to burr distal femur and continue.Surgery was completed using visualization tool to navigate to plan.

• Brand Name: NAVIO HANDPIECE TRACKER ARRAY
• Type of Device: 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: rick confer ; 2828 liberty ave; suite 100; pittsburgh, PA 38116 ; 4126833844
• MDR Report Key: 9254538
• MDR Text Key: 164245118
• Report Number: 3010266064-2019-00124
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628577
• UDI-Public: 00885556628577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PFSR120010
• Device Catalogue Number: PFSR120010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 136