MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN ANKLE ARTHRODESIS NAIL; NAIL, FIXATION, BONE

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Fracture (1260); Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 05/23/2014

Event Type  Injury  

Event Description

It was reported a patient underwent an ankle arthrodesis nail procedure on an unknown date.Subsequently, the patient was revised on (b)(6) 2014 due to bone non-union, a fractured screw, and the nail protruding out of the bone.The nail and screws were removed and no hardware was used to replace the explanted items.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Should additional information be received, biomet will forward a supplemental report to the fda.The following sections could not be completed with the limited information provided.Product identification and expiration date - unknown.Date implanted - unknown.Manufacture date ¿ unknown.

• Brand Name: UNKNOWN ANKLE ARTHRODESIS NAIL
• Type of Device: NAIL, FIXATION, BONE
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 3879449
• MDR Text Key: 19805398
• Report Number: 0001825034-2014-05554
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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