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

Catalog Number PFSR101209

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 10/28/2020

Event Type  malfunction  

Event Description

It was reported that during bilateral navio tka procedure anspach drill would not spin or expose during cut stage.The navio cart displayed the overheated drill error.This error occurred during the cut stage before any burring took place.The procedure was complete with an equipment swap.There was no impact on the case and no other complications.Delay reported less than 30 minutes.After the case, system was rebooted and drill test performed.Error was reproduced and anspach would not work properly.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The anspach drill used for treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The evaluation followed pv0005 rev.B.The reported problem was not confirmed.The drill functioned properly with no errors.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 associated with the part with the failure modes ¿overheating of device" and "overheating, e6 error¿ identified similar events.A relationship between the reported event and the device could not be established as there was no damage or problem found with the device during the visual and functional inspection.Although the reported problem was not confirmed a contributing factor may have been a lack of irrigation of the bur.Based on the investigation, no further containment or corrective action is recommended or required at this time.Our reference number: (b)(4).

• 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: 10863369
• MDR Text Key: 217071345
• Report Number: 3010266064-2020-02009
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NPFS02000