MAUDE Adverse Event Report: BIOMET TRAUMA HFN LH 130 DEG 11MM X 360MM; FIXATION, ROD

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Death (1802); Fall (1848)

Event Date 03/08/2016

Event Type  Death  

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 deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, "loosening, bending, cracking or fracture of the orthopaedic screw, intramedullary nail, plate, and screw-plate combination or loss of fixation in bone attributable to nonunion, osteoporosis, markedly unstable comminuted fractures." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-00844 / 00845).Requested but not returned by hospital.

Event Description

It was reported that patient underwent a left hip fracture fixation procedure on (b)(6) 2014.Subsequently, the patient was revised on (b)(6) 2016 due to nail fracture after a patient fall.Patient expired on (b)(6) 2016 due to unknown reasons.No further information has been provided.

• Brand Name: HFN LH 130 DEG 11MM X 360MM
• Type of Device: FIXATION, ROD
• 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: 5489864
• MDR Text Key: 39990716
• Report Number: 0001825034-2016-00844
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100238
• 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: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 814611360
• Device Lot Number: 778540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2013
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 159