MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ANSPACH DRILL, EMAX 2 PLUS; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED

Catalog Number 100338

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 05/23/2014

Event Type  Injury  

Event Description

It was reported that during procedure, when the surgeon had burred about halfway through the femur and then switched to speed control to finish the posterior portion the anspach drill would not hold the bur.After the bur fell out the first time the scrub tech took everything apart and put the long attachment and the bur back onto the anspach drill.The long attachment and the bur were checked to make sure it was locked into place, and both were locked in.After about 30 seconds of burring, the bur would fall out again.The scrub tech continued to take it apart and put it back together but the bur kept falling out.It did not matter if it was in speed or exposure control.At this point the anspach that was used on the first case was being flashed so we had to wait 10-15min to replace the anspach drill.During this 10-15min he tried to continue burring and eventually just used a saw to finish the tibia.Once it was replaced the anspach drill, it was working properly and the doctor was able to use the bur to finish the case.Investigation revealed there was no problem found with the drill.

Manufacturer Narrative

H10: h3, h6: the device was used in treatment and it was reported that the drill would not hold the bur.The dhr could not be reviewed and it was not confirmed if the product met manufacturing specifications.A complaint history found similar reports, this issue will continue to be monitored.This is an identified failure mode within the risk assessment.The surgical system user's manual released at the time of the complaint (pn 500054 rev a) provides complete and detailed instructions for bur assembly.We could confirm there was a relationship established between the reported event and the device.The device was returned for investigation.The evaluation of the device done by the oem revealed that the returned device was evaluated, and the reported problem was not confirmed.A visual and functional assessment was performed and found that the device meets all manufacturer's specifications.No problem was identified with the device.

• Brand Name: ANSPACH DRILL, EMAX 2 PLUS
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; ste 40; plymouth, mn
• MDR Report Key: 9994154
• MDR Text Key: 188813416
• Report Number: 3010266064-2020-00131
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K123380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 100338
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1