MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE UNICONDYLAR KNEE SYSTEM,; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 101026

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

The surgeon experienced difficulty aligning the keel punch into the slot on the trial sizer.Rather than adjusting, the surgeon abandoned proper preparation of the keel and instead impacted the tibial trial to punch the keel.This is improper use of the stride instrumentation provided.The surgeon did not adequately prepare the keel before impacting the tibial trial and therefore, the tibia fractured upon impact of the blunt trial keel into the unprepared tibia.The surgeon disregarded administered training and instructions for use on the appropriate preparation of the keel prior to impacting the trials, resulting in patient injury.

Event Description

At the end of a ukr procedure using the navio, the surgeon began trialing the stride implants and the patient's tibial plateau fractured.The fracture was through the center of the plateau (not along the lateral edge near the sagittal cut or keel).After the case, we discussed the fracture with dr.(b)(6) and got his thoughts on what might have caused the fracture.Dr.(b)(6) had difficulty getting the keel punch into the slot in the trial sizer and was not able to adequately prepare the keel, so he was using the trial to punch the keel.The surgeon had to convert to a tka with a stemmed tibial component.

Event Description

It was reported that at the end of a navio and stride case, while trialing implants patient's tibial plateau fractured.The fracture was through the center of the plateau (not along the lateral edge near the sagittal cut or keel).Doctor had difficulty getting the keel punch into the slot in the trial sizer and was not able to adequately prepare the keel, then used the trial to punch the keel.Surgeon had to convert it to a total knee replacement.

Manufacturer Narrative

H10 h3, h6: the device, used in surgery, was not made available to the designated complaint unit for investigation.Thus, visual and functional inspection could not be performed.There was no serial number, lot number, or part number noted in the initial investigation documents so we are unable to conduct a dhr review as a part of the investigation.Complaint history review found that this was the first occurrence of this issue.This failure mode is an identified risk in the risk file.The surgical technique, manual instrumentation, and product specifications for the stride unicondylar knee system provides instructions for prepping and punching the tibial keel using the trial impactor or keel punch and trial sizer.It was reported that the user placed the tibial trial and impacted it in order to "punch" the keel.Stride trials are not designed to be used as a keel punch, the keel is not sharp to pierce the bone, and rather it is dull and rounded.It is found that this impact force on the trial's keel caused the fracture of the patient's knee.The root cause of this issue is user error.A relationship between the device and the reported event could not be established.

• Brand Name: STRIDE UNICONDYLAR KNEE SYSTEM,
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; ste. 40; plymouth, mn MN 55441
• MDR Report Key: 6233919
• MDR Text Key: 64206117
• Report Number: 3010266064-2017-00002
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 68