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 11/05/2020

Event Type  malfunction  

Event Description

It was reported that, during femur cut stage of a navio tka procedure, it was found that the error activated on the anspach drill console.The anspach drill was reconnected and the assembly rechecked (long attachment, burr drill and handpiece) was correct, but the error persisted.No cuts could be done by this drill.They swapped for the drill for its backup to continue with a delay of fewer than 30 minutes.After the surgery, the anspach drill was checked in the admin mode and, as soon as the drill was connected to the console, the error was activated.The drill was confirmed faulty.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio drill, part number: 101209, s/n: (b)(6), used in treatment, was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.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 has identified prior events.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptoms may have been an electronic 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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

H3, h6: the anspach emax 2 plus hand piece - rohs, part number pfsr101209, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.A performance verification was followed.The customer handpiece was connected to the navio console and an "e6" error was outputted.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 has identified prior events.The most probable cause of the reported problem is electrical failure within drill cable.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: 10889462
• MDR Text Key: 217924851
• Report Number: 3010266064-2020-02033
• 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,Followup
• Report Date: 09/29/2021

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: 09/23/2021
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 08/03/2021; 09/29/2021
• Supplement Dates FDA Received: 08/03/2021; 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROB00036, SERIAL: SN: (B)(6)