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

Catalog Number PFSR101209

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/02/2020

Event Type  Injury  

Event Description

It was reported that during bone removal in a navio ukr procedure, the anspach drill was not able to retain the bur into the chuck.The surgery was converted to manual procedure with a delay of 15 minutes.No other complications were reported.

Manufacturer Narrative

H3, h6: the device (pn: 101092, 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 user's manual (500196) navio surgical technique guide (500197) provide instructions for drill setup for the bur, troubleshooting, and usage.We were able to confirm if there was a relationship established between the reported event and the device.The reported problem was not confirmed visually, but functional evaluation found that the when a bur was inserted into the device, the bur would unseat in the locking mechanism and disengage.This is indicative of damage to the locking mechanism, which is typically caused by wear over time.Based on the investigation, no corrections or corrective actions required at this time.The medical evaluation found that per complaint details, the device (anspach drill/bur) malfunctioned during bone removal of a ukr.It was communicated that the navio¿ was abandoned and the surgery was completed using conventional instruments with a delay of approximately 15 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 15-minute surgical delay would not be anticipated as the case was reportedly completed with conventional instrumentation.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: 10875181
• MDR Text Key: 217323555
• Report Number: 3010266064-2020-02019
• 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: 05/19/2021

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?: Yes
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention