MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO ROBOTICS INSTR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02000

Device Problems Connection Problem (2900); No Apparent Adverse Event (3189)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2020

Event Type  malfunction  

Event Description

It was reported that during preventive maintenance, while changing the ups battery there was an issue with the battery connector.No patient was involved.No other complications were reported.

Manufacturer Narrative

G3, h2, h3, and h6: the navio surgical system (us) ups battery, product 200029, lot 2531avhsm875900201, intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was confirmed.The reported problem was visually confirmed.The minus terminal was damaged during the battery replacement process.A functional evaluation could not be performed due to broken/damaged parts.The battery terminal is permanently damaged.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.The most likely cause of this event is improper handling of the part.The battery leads arced removing metal from the terminal when the service tech was inserting the battery into the ups.Refer to the product service instructions that provide guidelines for replacing the battery.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.D4, d8, d9 and h5: device returned.D10: add concomitants.G1: address updated.G4: add 510k code.H6: code update.

• Brand Name: NAVIO ROBOTICS INSTR
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• MDR Report Key: 10203845
• MDR Text Key: 196930091
• Report Number: 3010266064-2020-01608
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN NAVIO ROBOTICS INSTR/UNK