MAUDE Adverse Event Report: BIOMET TRAUMA ANKLE LOCKING NAIL 10 X 180MM; ROD, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 10/17/2016

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: bending or fracture of the implant and pain, discomfort, or abnormal sensation due to the presence of the device concomitant products: 14-405040 lot 756480 ti-double lead cortical 5.0x40mm screw; 14-405060 lot 756570 ti-double lead cortical 5.0x60mm screw.

Event Description

It was reported that patient underwent a revision procedure due to an ankle nail fracturing approximately 5 years post implantation.It was also reported that the patient retained a foreign object.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.As returned the nail is fractured through the slot on the end of the nail proximal to the guide connection.The portion of the nail distal to the targeting guide was not returned.The nail meets print specifications where measured.The threads of the returned screws are damaged consistent with smearing against the nail.Material analysis conducted showed the fracture site to be consistent with a fatigue fracture.A definitive root cause cannot be determined with the information provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: ANKLE LOCKING NAIL 10 X 180MM
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6109349
• MDR Text Key: 60181312
• Report Number: 0001825034-2016-04711
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK091976
• 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: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 14-440118
• Device Lot Number: 024630
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/01/2017; 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2011
• 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; Disability
• Patient Age: 80 YR
• Patient Weight: 60