MAUDE Adverse Event Report: BIOMET TRAUMA UNKNOWN TRAUMA

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification were not provided for the patients mentioned in the journal article.The article was written by olga d.Savvidou, michael beltsios, vasileios i.Sakellariou, andreas f.Mavrogenis, michael christodoulou, panayiotis j.Papagelopoulos.Product location unknown.

Event Description

Information was received based on review of a journal article titled, "use of external fixation for perilunate dislocations and fracture dislocations," which aimed to review clinical and radiographic outcomes of perilunate dislocations and fracture dislocations treated with external fixation and k-wire fixation.Eight patients identified in the article reported a good cooney score, six patients reported a fair cooney score, and two patients reported a poor cooney score.These scores may indicate pain with normal use of the device.

• Brand Name: UNKNOWN TRAUMA
• 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: 5888465
• MDR Text Key: 52505505
• Report Number: 0001825034-2016-03176
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other