MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; LPI IMPACTOR HANDLE

Catalog Number 213-65-00

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/17/2017

Event Type  malfunction  

Event Description

It was reported that it was reported that during an orthopedic knee surgery the lpi impact handle broke.The sales representative was not present at the surgery.It was reported no device fragments fell into the surgical site.The surgery continued and was completed without additional issues.There was no reported delay of surgery and there was no reported patient injury, adverse event, or clinical consequence to the patient.No additional information was provided by the reporter related to this event.

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.The device in question was returned to exactech for analysis.Design-related issues: the design of this lpi impactor handle has been in the field since 2009.(b)(4).Therefore, this issue does not appear to be design related.Mfg-related issues: exactech is not aware of any other complaints involving parts from this manufacturing lot, which has been in the field since 2011.Therefore, this issue does not appear to be manufacturing-related.Risk management: a review of the risk management report (rmr) was conducted to ensure the risk was included and the occurrence is below the thresh old.The rmr for this lpi impactor handle, 750-2003-019- rmr-instruments rev-, was reviewed.The risk is captured in line 23.Corrective action is not required because the occurrence rate is "very low", and the risk is captured in the rmr.Most likely cause: the deformed device reported was likely the result of multiple applications of high force during normal use.Exactech ifu 700-096-004 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 total knee arthroplasty 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 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 instrument malfunction is related to any manufacturing issues or design issues, nor did it lead to any reported patient impact.An investigation was conducted that the most likely root cause of the disassembly reported in this event was likely due to multiple surgeries, the lpi impactor breaks due to multiple applications of high force during normal use.Information was not provided for: pt.Info.

• Brand Name: EXACTECH
• Type of Device: LPI IMPACTOR 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: 13937976
• MDR Text Key: 298138616
• Report Number: 1038671-2022-10003
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 213-65-00
• Device Lot Number: 45182001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• 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): Other