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

Catalog Number PFSR101209

Device Problem Overheating of Device (1437)

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

Event Date 08/10/2021

Event Type  malfunction  

Event Description

It was reported that, in preparation for a navio demo, they ran the drill test and the anspach console displayed an intermittent error.The burr, long attachment and collar were locked in place securely and no moisture appeared to be present on the connector pins.No case involved; therefore, there was no patient involvement.

Manufacturer Narrative

H3, h6: the anspach emax 2 plus hand piece - rohs, part number pfsr101209, serial (b)(6) and intended to be used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.A performance verification was followed to troubleshoot the drill.The navio console did not output an "e6" during testing, and no related failures were observed during testing as well.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is the user may have run the drill in an improper manner/for a longer-than-expected timeframe that led to overheating of the internal motor assembly.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: 12356200
• MDR Text Key: 267828641
• Report Number: 3010266064-2021-00615
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• 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: 09/21/2021

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: 08/31/2021
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1