MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES GUIDE, CUTTING, DISTAL, MEDIUM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 101396

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2017

Event Type  Injury  

Event Description

It was reported that during a case, the anterior tka cut block was positioned on the patient.When the surgeon tried to drill the pin hole for the block, the 1/8th in drill bit went in but would not come out of the hole.In an effort to pull the drill bit out, it appeared to weld to the block.After making the distal femoral cut, the surgeon malloted the block up and off the femur.There was no surgical delay or patient injury reported.Per investigation, the drill bit used was not the proper pin that is prescribed to be used with the cut blocks.

Manufacturer Narrative

The device, used in treatment, was not made available to the designated complaint unit for investigation.Thus, visual and functional inspection could be performed.It was reported that when the when the surgeon tried to drill the pin hole for the tka cut block, the 1/8th inch drill bit went in but would not come out of the hole.The drill bit became stuck in one of the tka cut blocks.Upon review, it was found that the drill bit used was not the proper pin that is prescribed to be used with the cut blocks.These bits have not been tested with the cut blocks and therefore cannot be recommended for use.A review of the dhr found that for all lots for this part number, all of the quantity received was accepted with no other issues that would potentially lead to a future performance issue.A complaint history review found similar reports.This issue will continue to be monitored.This failure is an identified failure mode within the risk file.The surgical technique guide released at the time of the complaint provides instructions for using the cut guide.Functional evaluation from the initial investigation found that the pin that was stuck in the cut guide was not the prescribed 1/8" non-rimmed speed pin because it was threaded.Therefore, the user did not follow the instructions in the ifu.The probable cause for this issue was a user error.

• Brand Name: GUIDE, CUTTING, DISTAL, MEDIUM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9994346
• MDR Text Key: 189584148
• Report Number: 3010266064-2020-00396
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101396
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention