MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; TRULIANT TIBIAL INSERT HANDLE

Catalog Number 02-029-29-1000

Device Problem Failure to Disconnect (2541)

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

Event Date 12/29/2017

Event Type  Injury  

Event Description

It was reported from the us that during an orthopedic surgery the surgeon experienced an issue with the instrumentation.During routine total knee replacements, the tibial insert handle stuck in both the tibial insert trial and tibial tray trial.Most noticeably, the handle stuck hard in the tibial tray trial.After the trial was pinned into place on the tibia, the handle stuck when the surgeon tried to remove it to the point that it lifted the pinned tray trial off the tibia.The tray trial had to be repined to the tibia.There was no significant delay to surgery, but it was noted that the two prongs of the tibial insert handle were bent and scuffed.The patient was stable leaving the o.R.The device was received for analysis.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 (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.The complaint product was received for analysis.The reported condition of the handle getting stuck in the tibial trial and tibial insert was confirmed.The failure mode had been previously investigated under (b)(4) truliant tibial insert handle redesign.Under the capa it was found that the pins of the instrument were disassociating from the main body of the handle.This was due to deficiencies in manufacturing in which there was an insufficient laser weld and use of a slip fit vs the specified press fit reduced the efficacy to the pin- to -main body adhesion.Design improvements were implemented to bolster the pin to main body interface.The device in this complaint was manufactured and/or used prior to implementation of corrective actions.No further action is required.Exactech ifu 700-096-004 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 total knee arthroplasty 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 exactech instrumentation, devices and proficient with surgical techniques.This device is used for treatment not diagnosis.Based on a review of all available information, there is no evidence to reasonably suggest the reported event is related to manufacturing issues.No patient adverse event was reported, the tray trail had to be repined.The failure mode had been previously investigated under (b)(4) truliant tibial insert handle redesign.Under the capa it was found that the pins of the instrument were disassociating from the main body of the handle.This was due to deficiencies in manufacturing in which there was an insufficient laser weld and use of a slip fit vs the specified press fit reduced the efficacy to the pin- to -main body adhesion.

• Brand Name: EXACTECH
• Type of Device: TRULIANT TIBIAL INSERT HANDLE
• 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: 13451170
• MDR Text Key: 289210793
• Report Number: 1038671-2021-10081
• 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: 12/30/2021

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: 02-029-29-1000
• Device Lot Number: 85226001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• 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