DISCLAIMER: The following steps are summarized and do not constitute full operative instruction. Please refer to the package insert(s) or other labeling associated with the devices identified in the full surgical technique for additional information.

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BME ELITE Drill Guide kit used to determine implant bridge size and configuration for hallux valgus deformity correction.

  • ​​Determine the correct Implant bridge size and configuration using the BME ELITE™ Drill Guide Kit.​ 

Note: Leg lengths will be selected in Step 5 using the Depth Gauge.

Determine Implant Placement

  • While ensuring that both bones are in full contact, place the chosen Drill Guide across the fusion site. 

  • All prongs of the Drill Guide should be in contact with bone, which may require contouring of the bone surface to properly seat the Drill Guide. 

  • Accurate positioning can be accomplished by driving K-wires into the drill tubes and verifying placement with fluoroscopy. 

Note: Level fusion site to ensure Drill Guide sits flush to prevent Drill Guide rocking. 

BME ELITE Drill Guide kit used to determine drill holes for hallux valgus deformity correction

  • Drill the first hole through the far cortex or until the positive stop, which corresponds to 27 mm, is reached. 

Note: The EL-25S Drill guide is used for both the EL-2520S2 (2-leg) and EL-2520S4 (4-leg) implants. The white circles on the outer-most holes of the drill guide denote the drill holes to be used when using the drill guide for the EL-2520S2 (2-leg) implant. (Figure 1).

BME ELITE Drill Guide kit used to insert pull pins for hallux valgus deformity correction

  • Insert a Pull Pin into the first hole and repeat Step 3 to create each additional hole. 

  • The Drill Guide can be removed leaving the Pull Pins in place to mark the position of the drill holes. 

Tip: To ensure proper placement, fluoroscopy may be used prior to removing Pull Pins. 

Note: When using BME ELITE™ Y Implant, drill the first hole nearest the Drill Guide handle to aid with Implant placement. 

BME ELITE Depth Gauge used to determine depth of drill holes for hallux valgus deformity correction.

  • Remove the Drill Guide and Pull Pins and use the Depth Gauge to determine the depth of the drill holes and to select the appropriate Implant leg length. 

  • For bicortical drilling, use the hook on the pin of the Depth Gauge to engage the opposite face of the bones and determine the depth. 

  • For monocortical drilling, insert the pin as far into the hole as possible and add 1 mm to the depth reading obtained. 

  • The Depth Gauge is accurate to within +/- 1 mm. 

BME ELITE Implant aligned with drill holes for hallux valgus deformity correction.
  • Remove the Insertion Tool containing the selected BME ELITE Implant from the Implant Kit and align the tips of the legs of the Implant parallel with the drill holes. 
     
BME ELITE Implant inserted into drill holes using insertion tool for hallux valgus deformity correction.

  • Insert the BME ELITE Implant as far as possible into the predrilled holes. 

Tip: To ensure proper Implant placement, fluoroscopy may be used prior to releasing the Implant.

BME ELITE Implant inserted into drill holes using insertion tool for hallux valgus deformity correction.

  • Pull and hold the slider button away from the Implant to release the Implant from the Insertion Tool. 

Note: Ensure that the prongs of the Insertion Tool have disengaged completely from the Implant prior to removing the Insertion Tool. This should prevent accidental lifting of the Implant from the surgical site. 
 

Option: Second Orthogonal Implant 

  • If Implants are to be placed 90° to each other, do not tamp down the first Implant and repeat steps 1 to 8 with the second Implant. 

  • Use the first Implant’s raised bridge to align the Drill Guide for the second Implant. 

  • A K-wire can be placed through the Drill Guide and the placement checked under fluoroscopy to confirm that the legs of the second Implant will not interfere with the original Implant. 

Note: Aim the medial implant placement plantarly away from the intercuneiform joint as needed. 

BME ELITE tamp used to seat implant for hallux valgus deformity correction.
  • Align the Tamp with the bridge of the Implant and use as needed to completely seat the Implant.
BME ELITE Implant fully inserted foot bones for hallux valgus deformity correction.

  • Repeat Steps 1 to 9 for each additional Implant used.

Removal

  • Expose the site and the bridge of the Implant. 

  • Use the forceps or the needle driver to grasp the Implant and remove. 

Note: If the Implant is recessed, use an elevator to lift the Implant bridge and then use forceps to remove the Implant. If solidly connected, implants can be removed by either cutting the bridge of the implant or cutting the leg of the implant near the bridge and removing the remnants with an elevator. 

The above steps are an overview of the surgical technique. Complete information regarding indications, contraindications, warnings, care, and caution can be found in the Instructions For Use.