MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 101111

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/07/2018

Event Type  Injury  

Event Description

It was reported that osterior cortex of the patient's tibia developed a small fracture across the tibial bone pin sites during placement of the 4.0 pins during the procedure.The surgeon drove the 4.0 pins bi-cortically, as per technique guide instructions, and heard the crack upon doing so for each pin in the tibia.Dr.Chose to move forward with the procedure confident that the array construct was solid.His technique for tightening the arrays included handling both the array clamp and pins while tightening with the t-handle.X-ray was taken at the end of the procedure and small fractures were confirmed.Patient will be put on rehab precautions during recover.

Manufacturer Narrative

H3, h6: the device, used for treatment, was not returned for evaluation.The initial investigation results indicated that the posterior cortex of the patient's tibia developed a small fracture across the tibial bone pin sites during placement of the 4.0 pins during the procedure.Visual inspection of the x-ray provided by the site confirmed small fractures across the tibial bone pin sites.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review identified 2 prior similar events.This failure mode is identified within the risk assessment.The navio surgical technique for tka released at the time of the complaint includes instruction for proper bone tracker placement and use of the bone pins.The surgical technique further states in the tibia tracker array placement section, "slowly drill the bone pin into the tibia, perpendicular to the bony surface, taking care to engage the opposing cortex and stop." we were able to confirm there was a relationship established between the reported event and the device.The malfunction was a preventable issue, which occurred due to the surgeon not following the instructions for bone pin insertion engagement in the second cortex.

• Brand Name: SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9998614
• MDR Text Key: 189449363
• Report Number: 3010266064-2020-00557
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101111
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• 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
• Patient Age: 69 YR