As a result of an fda inspection conducted in (b)(6) 2020, exactech, (b)(4), has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.Device(s) not available for analysis.Engineering eval completed by mb on (b)(6) 2018.Design-related issues: the design of the talar trial has been in the field since 2015.Exactech has not received any other complaint reports involving talar trials since 2015.Because the talar trial is used in total ankle surgeries, sales data for tibial component was used to calculate an approximate complaint occurrence rate of <0.5%.This is considered "very low" according to the frequency of occurrence ranking scale.Therefore, this issue does not appear to be design related.Mfg-related issues: no information regarding the serial number or manufacturing lot was provided.However, according to engineers on the ankle team, the supplier was not "breaking all edges" during manufacturing which may have caused the reported issue.A review of the process failure mode effects analysis (pfmea) was conducted to ensure the risk was included and the occurrence is below the threshold.The pfmea for this talar trial, (b)(4), was reviewed.The metal shavings reported in experience (b)(4) were likely due to the supplier not "breaking all edges" in accordance with the print.(b)(4): wear in total ankle replacements is a known failure mechanism.Retrieval studies have documented debris trapped at the bone interface of these components as well as in the articular surface ((b)(4)).However, no retrieval studies indicated the presence of stainless steels commonly used in surgical instruments.Studies that identified the debris either in the bone or at the articular surface found that they were likely from the implant (ha, titanium, polyethylene).Given the published evidence of debris in the joint, the likelihood that debris from this instrument would accelerate or increase this mechanism is considered low.Osteolysis around ankle implants is commonly found in the literature.It can manifest as bone cysts or bone loss at the implant-bone interface.In cases where this lysis is progressive, it can require surgical intervention to fill voids or revise components.At this time there is no evidence that debris generated by instrumentation intraoperatively has caused early implant failure.Retrieval studies indicate the implant material is most commonly found in the articular surfaces and surrounding bone.Thus, the severity is considered minor.Pulse lavage is used throughout the total ankle procedure to clear any debris generated at the time of surgery.The presence of metal debris generated while drilling the talus holes is expected to be cleared by this technique.This is supported by retrieval studies that have documented materials found in the interface are not stainless steel, but rather hydroxy-apatite, titanium or polyethylene.Ifu states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: (1) appropriate reading of the literature, and (2) training in the operative skills and techniques required for surgery, and (3) reviewing information regarding use of instrumentation.It is a clinical standard of practice in the operating room that all instruments should be visually and functionally inspected before use, these guidelines are from standard association of peri-operative registered nurses (aorn) guidelines.Surgeons are to be familiar and knowledgeable with all instrumentation, devices and proficient with surgical techniques.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any design issues.There is no reported patient adverse event.There were metal shavings on the talus when using the new talar trials.Metal debris on the instrument can get into the joint articulation or the bone implant interface.The surgeon cleaned the area with pulse lavage and confirmed it was removed.An investigation was conducted: the metal shavings reported were likely due to the supplier not "breaking all edges" in accordance with the print.
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