MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 4.5MM CORT NON-LOCK SCREW 30MM; DEVICE, FIXATION

Model Number N/A

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 07/16/2015

Event Type  Injury  

Manufacturer Narrative

The following sections could not be completed with the limited information provided.The patient was born on an unknown date in 1935.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, number 2 states, ¿bending or fracture of the implant.¿ date of birth - 1935.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2016-02231 / 02233).A non-locking screw was reported to have fractured; three non-locking screws were implanted during the procedure and it is unknown which fractured.Used/remains implanted.

Event Description

A patient enrolled in a clinical study, during the right hip fracture procedure the head of a non locking screw fractured upon insertion.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

A patient enrolled in a clinical study, during the right hip fracture procedure the head of a non locking screw fractured upon insertion.The patient retained the shaft of the fractured screw.

• Brand Name: 4.5MM CORT NON-LOCK SCREW 30MM
• Type of Device: DEVICE, FIXATION
• 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: 5743271
• MDR Text Key: 47994013
• Report Number: 0001825034-2016-02232
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 14-455032
• Device Lot Number: 891640
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2015
• 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): Required Intervention; Disability
• Patient Age: 80 YR
• Patient Weight: 77