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

Catalog Number PFSR120010

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 02/03/2017

Event Type  malfunction  

Event Description

During femur cutting, surgeon commented that he thought he was cutting way too much from the posterior femur; however, the bone model did not turn red. Prior to entering cutting, the femur checkpoint passed, so we were not concerned about the femur tracker's rigidity. Just after he commented about the depth, we switched to speed control and went back to planning to double check our posterior femur cut depth. The cut seemed well aligned with the mesh. When the scrub tech handed dr. Carangelo the handpiece, the tracker came off.

• 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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• Manufacturer Contact: richard confer ; 2828 liberty ave; suite 100; pittsburgh, pa ; 6833844
• MDR Report Key: 9993928
• MDR Text Key: 188841234
• Report Number: 3010266064-2020-00531
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: PFSR120010
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 04/23/2020 Patient Sequence Number: 1