MAUDE Adverse Event Report: EXACTECH, INC KNEE BLADE DRILL GUIDE

Catalog Number 521-11-02

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problems Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

Pending engineering evaluation.

Event Description

The femur resection was 14mm instead of 10mm.

Manufacturer Narrative

The complaint products were received for analysis.The reported event of a cutting error is verified and was the result of an incorrect instrumentation selection for the image guided system set-up, not a device malfunction.Visual evaluation condition/findings (conducted with a 7x or 10x optical)- all adjustment screws can be adjusted as expected.No visual discrepancies could be found with either instrument.According to the sales representative, this was a set-up error and not an issue with the actual instruments used.The company has not received any other complaints involving these devices, therefore, this event does not appear to be design or manufacturing related.User related issues are addressed in the most likely cause.The incorrect cuts reported were likely the result of inputting the incorrect cutting block into the image guided system during setup.The instruments performed as intended, the image guided system thought different instrumentation was in use.In review of labeling the surgeon profile creation is customized for the surgeons' preferences and technique, all tabs for the instruments and the steps for tibia and femur planning, each step can be visualized for verification before starting a procedure.It is also noted that only qualified surgeons who are fully knowledgeable about all aspects of surgical technique and are fully trained to use the system and instrumentation are to use these devices.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the incorrect cuts performed using the adjustable block and the knee blade drill guide were the result of incorrect image guided system set-up and the lack of verification by staff/surgeon of instrumentation before the surgical procedure began.This device is used for treatment, not diagnosis.

Event Description

It was reported that a surgeon made a 14mm cut instead of 10mm while using the image guided system.The sales representative did not put the surgeon's preference in the image guided system profile upon setup and there was also the failure of the surgical team to verify the proper attachment of the tracker to the instruments at the time of surgery.The technical log was reviewed by the image guided system company and there is discrepancy between the jig that was used to perform the cut and the one that was supposed to be used according to the system profile.Upon review of the two jigs, the orientation of the cutting slot relative to the tracker is the same, but there is a difference of 3.4 mm relative to the location.No extra time for the surgical case was noted, there was no harm to the patient relative to the surgical outcome.There is no allegation of device malfunction.No additional information has been provided.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00206.

• Brand Name: KNEE BLADE DRILL GUIDE
• Type of Device: DRILL GUIDE
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6449190
• MDR Text Key: 71582694
• Report Number: 1038671-2017-00207
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 521-11-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other