MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ANKLE LOCKING NAIL 11 X 150MM; ROD, FIXATION, INTRAMEDULLARY

Model Number N/A

Device Problem Failure to Osseointegrate (1863)

Patient Problem Non-union Bone Fracture (2369)

Event Date 04/08/2014

Event Type  Injury  

Event Description

It was reported patient underwent an initial ankle procedure on an unknown date in 2012.It was further reported patient was revised on (b)(6) 2014 due to non-union and subsequent fracture of the locking nail.Surgeon repaired the fracture using screws.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or associated deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "nonunion or delayed union, which may lead to breakage of the implant." number 11 states, " inadequate healing.".

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.The root cause of the event was determined to be due to overloading of the nail as a result of non-union.

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 11 X 150MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3800104
• MDR Text Key: 4522375
• Report Number: 0001825034-2014-03715
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK091976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2014

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?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 14-440215
• Device Lot Number: 147390
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 05/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/20/2014; 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2011
• 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