MAUDE Adverse Event Report: BIOMET TRAUMA HFN 125 DEG 11MM X 180MM; ROD, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Impaired Healing (2378); No Information (3190)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

No product or photos were received, therefore the condition of the device is unknown.This device is used for treatment.Current information is insufficient to permit a conclusion as to the cause of the event.Concomitant products: hfn lag screw catalog#: 814510090 lot#: rp1133290f, cortical bone screw catalog#: 814550032 lot#: dllb4b.

Event Description

Patient underwent a hip fracture nail revision approximately eighteen months post-implantation due to nail fracture by the lag screw junction.The patient was converted to a competitor total hip.

Manufacturer Narrative

This report is being amended to reflect additional information not known in prior submissions.Current information remains insufficient to permit a conclusion as to the cause of the event.

Event Description

It is reported that the patient underwent a hip fracture nail revision approximately eighteen months post-implantation due to delayed healing and nail fracture by the lag screw junction.Surgeon alleges no deficiency in the device, and that the device fracture was caused by the delayed healing.The patient was converted to a competitor total hip.

Manufacturer Narrative

This report is being amended to reflect additional information not available at the time of the initial report.Current information remains insufficient to determine the cause of the event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HFN 125 DEG 11MM 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6190892
• MDR Text Key: 62905180
• Report Number: 0001825034-2016-05185
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 814311180
• Device Lot Number: DPGCF7
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 87 YR