MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UNKNOWN CORI DEV; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 74013489

Device Problem Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 07/23/2020

Event Type  Injury  

Event Description

It was reported that during a cori tka procedure, when using the 3.2 mm x 110 mm speed pins on the tibia, the pin got stuck in the speed pin driver.They tried to separate the pin from the driver, but it remained stuck and completely pulled out of the tibia as he pulled on the drill.They switched to the 4.0 x 127 mm bone pin for the tibia.They were able to resume without any issue.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this complaint from the unites states reports that during a cori total knee arthroplasty the camera kept disconnecting and while using the speed pin quick connect adapter ¿ the pin got stuck in the driver and pulled completely out of the tibia.The surgeon switched to the 4.0 x 127 mm bone pin for the tibia.They were able to resume without any issue.There was no impact/harm/injury as a result of this reported event.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKNOWN CORI DEV
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10425642
• MDR Text Key: 203502986
• Report Number: 3010266064-2020-01718
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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: 74013489
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention