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

Catalog Number 100338

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2014

Event Type  Injury  

Event Description

It was reported that during procedure, the anspach drill started smoking slightly while in use on the tibia.The physician completed the surgery with the same device.No injuries occurred, nor did the incident affect the outcome of the surgery.

Manufacturer Narrative

The device was used in treatment and it was reported that the drill started smoking slightly while in use.The surgeon finished the case with this device.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.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 the drill started smoking slightly while in use.The surgeon finished the case with this device.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: 9994151
• MDR Text Key: 188787629
• Report Number: 3010266064-2020-00130
• 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?: No
• Is this a Product Problem Report?: Yes
• 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