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

Catalog Number PFSR101209

Device Problem Interrogation Problem (4017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2020

Event Type  Injury  

Event Description

It was reported that during bone removal phase in a navio ukr procedure, after few seconds the anspach drill stopped working and error message e6 appeared on the anspach console.They tried three times after reconnecting the drill connector and foot pedal, but it was not solved.The surgery was changed to manual procedure.No other complications were reported.

Manufacturer Narrative

H3, h6: the device (pn (b)(4), sn (b)(6)), used in treatment, was returned for investigation.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the risk profile.The navio surgical technique guide ((b)(6)) provides instructions for drill usage and troubleshooting.We were not able to confirm if there was a relationship established between the reported event and the device.The reported problem was not confirmed visually.Functional evaluation was performed where the drill was connected several times to recreate the reported e6 error and no codes were presented and the drill ran the drill test successfully with no issues.No problem found with the device.The e6 error is indicative of the device overheating.When the e6 error occurs, the drill should be unplugged and allowed to cool for about a minute before restarting.Based on the investigation, no corrections or corrective actions required at this time.Medical investigation found that per complaint details, the device (anspach drill) malfunctioned during bone removal in a ukr procedure.It was communicated that the navio¿ was abandoned after several troubleshooting attempts failed to resolve the error and the surgery was completed using conventional instruments with a delay of approximately 10 minutes.Per the field report, no patient harm or additional complications were reported.Based on this information, patient impact beyond the reported modified procedure and the approximate 10-minute surgical delay would not be anticipated as the case was reportedly completed with conventional instrumentation without patient harm/injury, without significant delay and the surgeon was pleased with the surgical outcome.No further medical assessment is warranted at this time.

• Brand Name: ANSPACH EMAX 2 PLUS HAND PIECE - ROHS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10875718
• MDR Text Key: 217347442
• Report Number: 3010266064-2020-02024
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention