Safety of Treatment of Shoulder Repair

This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the HEALICOIL Knotless Suture Anchors in subjects with either rotator cuff repair and/or biceps tenodesis. Approximately 160 subjects will be enrolled at up to 6 sites. Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative follow up, clinical complications, reoperation rate, EQ-5D-5L, and pain VAS.

Inclusion criteria

• Requires reattachment of soft tissue to bone for the following shoulder indications:

• Rotator Cuff Tendon repair:

• i. Single or double row rotator cuff repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping; OR
• ii. Double row rotator cuff repair using HEALICOIL Knotless RG NST in lateral row (existing HEALICOIL RG device to be used in medial row of the repair); AND/OR
• Biceps tenodesis

• i. In conjunction with Rotator Cuff Tendon repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, HEALICOIL Knotless RG NST or HEALICOIL Knotless RG Self-Tapping OR
• ii. As a stand-alone procedure for HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping (not HEALICOIL Knotless RG NST
• Has a pre-operative MRI collected within 6 months of surgery which meets one of the following criteria:

• MRI collected as standard-of-care has been submitted to external imaging vendor and confirmed as acceptable OR
• If standard-of-care images are unavailable or considered unacceptable by external imaging vendor, subject must undergo an additional study-specific pre- operative MRI, confirmed as acceptable by external imaging vendor OR
• MRI not required; subject not in HEALICOIL Knotless RG NST subgroup
• Has consented to participate in the study by signing the IRB/IEC approved informed consent form.
• Requires only one variant of the HEALICOIL Knotless Suture Anchor
• Is ≥18 years of age at time of surgery
• Willing and able to make all required study visits
• Able to follow instructions (Approved translated documents supplied upon request)

Exclusion criteria

Any one (1) of the following criteria will disqualify a potential subject from participation in the study:

• Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
• Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
• Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
• Comminuted bone surface, which would compromise secure anchor fixation.
• Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing
• The presence of infection.
• Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
• Concurrent bilateral surgery.
• Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
• Women who are pregnant.
• Prior ipsilateral surgeries performed on the joint space.
• Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.