MAUDE Adverse Event Report: EXACTECH, INC. 2-1 FEMORAL CUT BLOCK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number 2-1 FEMORAL CUT BLOCK

Device Problem Positioning Problem (3009)

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

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, the posterior femoral cut was referenced anteriorly after the 2-1 cutting block was not aligning with the distal femur, after milling.This caused a wafer of been to be removed posteriorly and the final implant was off bone by 1mm and not ideal fit.Cement was used to fit this, but hard to pressurize in this area.A 8mm poly final component would not fit, although 7 and 9 mm did with ease.Due to above concerns already mentioned, the posterior and champfer cuts were not precise and had to toggle the cuts for best fit.

Manufacturer Narrative

H1: this event was reported in error.Further review determined this complaint is related to product for which exactech acts solely as the distributor.All available information for this complaint has been forwarded to the original equipment manufacturer (oem) responsible for the regulatory reporting determinations, regulatory reporting and investigation of this complaint under their own quality system.

• Brand Name: 2-1 FEMORAL CUT BLOCK
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11740079
• MDR Text Key: 263400300
• Report Number: 1038671-2021-00202
• Device Sequence Number: 1
• Product Code: JWH
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2-1 FEMORAL CUT BLOCK
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1