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

Model Number PFSR110137

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 10/08/2020

Event Type  Injury  

Event Description

It was reported that, while burring the femur during a navo ukr procedure, the anspach drill came loose from the handpiece several times.The surgeon proceeded to reinsert the drill multiple times throughout the case which caused a delay of fewer than 30 minutes.This resulted in overcut of bone on the femur.There were no additional interventions due to this issue.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio, handpiece, part number 110137 sn: (b)(6) used for treatment was returned for evaluation.The reported problem was not visually confirmed.A functional evaluation was performed.The evaluation followed the handpiece performance evaluation.The reported problem was confirmed.The drill feels loose in the snap lock.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.This failure mode is identified in the risk profile.The most likely cause of this event is a mechanical component failure of the snap lock.Ensure that the final position of the drill is between 9:00 and 12:00 positions when viewed from the rear perspective.The arrow should not be visible on the left side when viewed from the rear.Based on the investigation, no further containment or corrective action is recommended or required at this time.The medical investigation found that per complaint details, while burring the femur during a navo ukr procedure, the anspach drill came loose from the handpiece several times resulting in a 0-30minute surgical delay and an over cut bone on the femur.Reportedly, the surgeon proceeded to reinsert the drill multiple times throughout the case and was able to complete the procedure using the same device and was ultimately satisfied with the outcome of the procedure.The virtual images provided in the log files show areas of over-burring in red inside and outside of the component footprint and support the complaint.It was communicated that ¿no patient was harmed/impacted/injured when this error occurred¿ and no additional interventions were required.In conclusion: based on the documentation provided, the patient impact beyond the reported over-burring, 0-30 minute surgical extension, and modified surgical procedure could not be determined as it was reported that the procedure was successfully completed using the same device without patient harm or injury.It is unknown if the procedure was converted to a manual technique due to the reported events.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10779090
• MDR Text Key: 214363914
• Report Number: 3010266064-2020-01949
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other