MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS; NAVIO

Catalog Number PFSR101209

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  Injury  

Event Description

It was reported that, during tka surgery with navio, during calibration, the system displayed a message to check the connections for the anspach drill.After further review, it was found that a pin was in the connector was recessed.The case was changed to manual procedure with a delay of fewer than 30 minutes.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio anspach emax 2 plus hand piece (poland), pfsr101209, s/n (b)(6) used in treatment was not made available to the designated complaint unit for evaluation, however visual inspection of a photo provided was performed.A relationship between the reported event and the device was visually confirmed.A pin in the connector was recessed.A functional evaluation could not be performed because the device was not returned.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 1 prior event.The most likely cause of this event is deformation (a recessed pin) due to compressive stress/excessive force or misuse by user.Refer to the product instructions for use "recovery procedure guidelines" table that provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.This failure is an identified failure mode within the risk assessment.There was a surgical delay of 30 minutes or less and the case was completed with manual instrumentation.No patient injury or impact was reported.Smith & nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received the complaint can be reopened.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: ANSPACH EMAX 2 PLUS HAND PIECE - ROHS
• Type of Device: NAVIO
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11787524
• MDR Text Key: 249390921
• Report Number: 3010266064-2021-00329
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR101209
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention