MAUDE Adverse Event Report: BIOMET TRAUMA TITANIUM DOUBLE LEAD CORTICAL SCREW 5MMX26MM; ROD, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 12 states, "early or late postoperative infection and allergic reaction." review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.This report is number 1 of 7 mdrs filed for the same patient (reference 1825034-2016-05042 - 05048).

Event Description

Patient underwent an ankle nail revision procedure approximately one year post-implantation due to infection.All components were removed.

Manufacturer Narrative

The root cause remains undetermined.

• Brand Name: TITANIUM DOUBLE LEAD CORTICAL SCREW 5MMX26MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 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: 6150178
• MDR Text Key: 61590742
• Report Number: 0001825034-2016-05042
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 14-405026
• Device Lot Number: 425060
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention