MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES GUIDE, CUTTING, TIBIA, TWIN PEGS, TKA, RIGHT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 101464

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  Injury  

Event Description

It was reported that during a tka procedure, the trocar pin got stuck in the twin peg tibia cutting block when attempting to pin the tibia block.Another tray was opened.There was a slight surgical delay with no patient injury.According to investigation, the pin used was not the one prescribed in the surgical technique for tka.

Manufacturer Narrative

The device, used in treatment, was returned for investigation.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found no 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.Specifically, the guide does provide instruction on how to secure the distal cut guide on the bone surface using 1/8" diameter non-rimmed speed pins provided in the smith & nephew implant system trays.Investigation of the returned cut guide found that the pin used was the threaded 5-inch trocar pin and was obviously impacted through the cut guide.Impacting the pin lends itself to bending the pin and becoming lodged in the cut block.The pin was ben and wedged itself inside the cut block.The functional evaluation suggest that the cause of the complaint was user error.We could confirm if there was a relationship established between the reported event and the device.Per complaint details, the device malfunctioned during use a 5inch trocar pin got stuck in twin peg tibia cutting block while attempting to pin the tibia block.Another tray was opened and used.There was a "slight delay, no injury to patient was reported.Based on the information provided the impact beyond the reported modified procedure and the surgical delay the patient injury/impact could not be determined.No further medical assessment is warranted at this time.

• Brand Name: GUIDE, CUTTING, TIBIA, TWIN PEGS, TKA, RIGHT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9996579
• MDR Text Key: 188862571
• Report Number: 3010266064-2020-00962
• 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
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Date Manufacturer Received: 08/24/2020
• Patient Sequence Number: 1
• Patient Age: 66 YR