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

Catalog Number 100338

Device Problem Overheating of Device (1437)

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

Event Date 02/10/2014

Event Type  Injury  

Event Description

It was reported that during the cutting stage the anspach drill started smoking.It then would not allow burring to continue.Both the tibia and femur had been cut except for the femoral peg and keel.Therefore it had been in use for about 20 minutes (approx).The peg and keel had to be cut using manual instrumentation.All normal protocol had been followed including using continous irrigation.

Manufacturer Narrative

H10 h3, h6: the device was intended for use in treatment and it was reported that that during a case, drill started smoking.There was no serial/lot number provided for dhr review so it could not be concluded if the device met the 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 information on drill usage and troubleshooting.We could not confirm if there was a relationship established between the reported event and the device.Photos of the device were not provided for evaluation and the device was not returned.Review of the information provided in the field report revealed that during a case, drill started smoking.The root cause was established to be undetermined after investigation.

• 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: 9994128
• MDR Text Key: 188809926
• Report Number: 3010266064-2020-00129
• 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,foreig
• 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?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1