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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2020

Event Type  malfunction  

Event Description

It was reported that during a navio saw bone demo, it was found that on connecting the anspach drill to the console, the e6 error is activated (overtemp error that indicates the drill is faulty).No patient was involved.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio anspach drill, part number 101209, serial number (b)(6), intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was confirmed.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.Upon connection to a known good navio system, an e6 error was displayed.A review of manufacturing 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 component failure.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.

• 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: 11090004
• MDR Text Key: 224303579
• Report Number: 3010266064-2020-02138
• 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: 07/28/2021

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: PFSR101209
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/06/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NAVIO SURGICAL SYSTEM INDIA ROB00036