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

Model Number	PFSR120010
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9254538
• Report Number: 3010266064-2019-00124
• Device Sequence Number: 2550353
• Product Code: OLO
• UDI-Device Identifier: 00885556628577
• UDI-Public: 00885556628577
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PFSR120010
• Device Catalogue Number: PFSR120010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 136