The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
The primary objective of the study is to assess performance, clinical benefits and safety of the EZPass Suture Passer and the Precision Flexible Reamer Instrumentation. Performance and clinical benefits will be assessed through an operative survey conducted immediately following intraoperative surgery to determine if the device performed as expected. Safety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions.
Study Type
OBSERVATIONAL
Enrollment
73
Instruments used to help with rotator cuff or ACL repair
OrthoCarolina
Charlotte, North Carolina, United States
Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)
Questionnaire was completed to assess if the Instrument Performed as Expected. Surgeon provided yes/no answers on their opinion if the instrument performed as expected during the procedure.
Time frame: Intraoperative
Absence of Instrument Related Serious Adverse Events
This outcome will measure the frequency of instrument related serious adverse events
Time frame: Intraoperative
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