Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures

This is an ambispective, multi-surgeon, single site, consecutive case series taking place in the United States. Once a subject is identified and informed consent is obtained from that subject, retrospective data will be collected from the subject's electronic medical record (EMR), and prospective data will be collected from subject-provided PROM's. A minimum of 16 and maximum of 23 subjects will participate in the study.

• Grappler Interference Screw System (Device): Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System

Primary outcomes

• Device performance and benefits as related to Foot and Ankle Mobility Measure [6 months post-operative]: Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction.
• Device performance and benefits as related to pain levels based on the Visual Analog Scale [6 months post-operative]: Device performance and benefits as related to pain levels based on the Visual Analog Scale (range: 0 to 100; 0 = no pain; 100 = worst pain imaginable)of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction.
• Device performance and benefits as related to pain levels based on Patient satisfaction [6 months post-operative]: Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)

Secondary outcomes

• Safety will be assessed by recording the incidence of secondary procedures related to the index device [6 months post-operative]: Safety will be assessed by recording the incidence of secondary procedures related to the index device

Sex: All

Inclusion Criteria:

* The subject underwent a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques
* The subject signs a written informed consent form (ICF)

Exclusion Criteria:

* None

• Jacy Legue, Study director, Paragon 28