MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO BONE PIN 4 MM OD X 5.0 (127 MM) IN LG; STEROTAXIC INSTRUMENT, COMPUTER ASSISTED

Catalog Number PFSR101111

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Investigation narrative: the navio surgical system surgical technique for total knee arthroplasty clearly 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." therefore, this was a preventable issue by the surgeon as the instructions for bone pin insertion clearly state to only engage the second cortex.The reporter noted in the field report that in future cases, the surgeon plans to stop penetration when the second cortex is engaged.

Event Description

It was reported that the posterior cortex of the patients tibia developed a small fracture across the bone pin sites during placement of the 4.0 tibial pins.The pins were driven bi-cortically and a cracking sound was heard for each pin placed in the tibia; however, the surgeon opted to continue the procedure confident that the array construct was solid.The arrays were tightened by handling both the array clamp and pins while tightening with the t-handle.An x-ray was taken at the end of the procedure which confirmed the tibial fracture.The surgeon intends to modify the technique used for future pin placement to mitigate bi-cortical placement by slowing down the drill after breaking through the first cortex and stopping pin penetration once the second cortex is sensed to avoid breaking through the second cortex.

Manufacturer Narrative

H10: b4, g4, h2, h3, h6: updated information.H11: a1, b5, d1, d4, g3, g5: corrected information.

Event Description

It was reported that, during a tka surgery, 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.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.The physician chose to move forward with the procedure confident that the array construct was solid.X-ray was taken at the end of the procedure and small fractures were confirmed.Patient was put on rehab precautions for recovering.The patient outcome is unknown.

Manufacturer Narrative

H10: the device, used for treatment, was not returned for evaluation.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 similar events.This failure mode will be trended to assess for any necessary corrective actions.The navio surgical technique for tka (pn 500146 rev b) 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." this failure mode is identified within the risk assessment.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.The surgeon plans stop in penetration when the second cortex is engaged for future procedures.Per complaint details, the device malfunctioned during use and the navio; two small fractures across the tibial bone pin sites occurred during placement of the 4.0 pins during the procedure.The surgeon has modified his pin placement and plans to mitigate bi cortical placement by slowing down the drill after breaking thru first cortex and stopping pin penetration once he senses the second cortex in hopes of avoiding any purchase thru the second cortex.The patient will be put on rehab precautions during recovery.Based on the information provided the impact beyond the reported modified procedure, the surgical delay and rehab precautions the patient injury/impact could not be determined.

• Brand Name: NAVIO BONE PIN 4 MM OD X 5.0 (127 MM) IN LG
• Type of Device: STEROTAXIC INSTRUMENT, COMPUTER ASSISTED
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW; 2905 northwest blvd.; suite 40; plymouth MN 55441
• MDR Report Key: 8111664
• MDR Text Key: 128637109
• Report Number: 3010266064-2018-00015
• 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,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PFSR101111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR