MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TIBIAL CUT GUIDE LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The information provided on this form was previously submitted under manufacturing report number 0001822565-2017-04222.(b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed,a supplemental medwatch 3500a will be submitted.

Event Description

It was reported through a persona partial knee operative survey that the corner pin (hole 2) of the tibial cut head, there was a risk of lesion to posterior structures if fully introduced.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that the patient was not injured.The initial report should be voided as it was submitted in error.

• Brand Name: TIBIAL CUT GUIDE LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6794771
• MDR Text Key: 82886982
• Report Number: 0001825034-2017-06364
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42539905185
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• 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: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 70