MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; TALAR TRIAL

Catalog Number 351-03-03

Device Problem Material Disintegration (1177)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2016

Event Type  Injury  

Event Description

It was reported that during an orthopedic surgery the surgeon experienced an issue with the talar trial.There were metal shavings on the talus when using the new talar trials.The sales representative was present at the surgery.The issue was resolved by getting a new talar trial.There was no adverse outcome to the patient.According to engineers on the ankle team, the supplier was not "breaking all edges" during manufacturing which may have caused the reported issue.Information from (b)(4): report of metal debris around the talar drill holes during preparation of the talus pegs.The surgeon cleaned the area with pulse lavage and confirmed it was removed.Multiple attempts were made for information during the initial investigation of this complaint in 2017.Inactive agency with no hospital/other contact information for the event.No additional information.

Manufacturer Narrative

As a result of an fda inspection conducted in jan 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 (b)(6) on 11 may 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 (b)(4).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) pfmea rev a, was reviewed.The risk is captured on page 13.The metal shavings reported in experience (b)(6) 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: appropriate reading of the literature, and training in the operative skills and techniques required for surgery, and 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.

• Brand Name: EXACTECH
• Type of Device: TALAR TRIAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 13451163
• MDR Text Key: 289503315
• Report Number: 1038671-2021-10079
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 351-03-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention