MAUDE Adverse Event Report: BIOMET TRAUMA 3.5X32MM CORT LOCK SCR STE; PLATE, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Staphylococcus Aureus (2058)

Event Date 06/08/2016

Event Type  Injury  

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.This is 16 of 17 devices being reported for the same event, as we are unable to determine which device was involved (reference 1825034-2016-03272 / 3285 and 1825034-2016-03287 / 3289).There are warnings in the package insert that state this type of event can occur: under possible adverse effects, it states, ¿infection, both deep and superficial.¿ this report is number 17 of 18 mdrs filed for the same event (reference 1825034-2016-03272 / 3289).

Event Description

Patient underwent a procedure to remove locking plates and screws in both lower extremities approximately four months post implantation due signs of infection in the left lower extremity.Nothing was implanted to replace the products as the patient's bones had healed and the patient was treated with antibiotics.

• Brand Name: 3.5X32MM CORT LOCK SCR STE
• Type of Device: PLATE, 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5906085
• MDR Text Key: 53085460
• Report Number: 0001825034-2016-03288
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• 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: 856135032
• Device Lot Number: 060500
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2014
• 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