MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNK PLATE; APPLIANCE, FIXATION

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Non-union Bone Fracture (2369)

Event Date 07/02/2014

Event Type  Injury  

Event Description

Patient reported to have fallen and was diagnosed with closed fracture of the middle third of the left clavicle with displacement.Patient underwent left open reduction internal fixation surgical procedure on (b)(6) 2014.Subsequently, a revision procedure was performed on (b)(6) 2014 due to nonunion of the fracture, pain and infection.The plate and screws were removed and the wound was irrigated and debrided.It is reported that patient will undergo another orif stage with bone graft.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided: catalog number, lot number and expiration date - unknown.510k number - unknown.Manufacture date ¿ unknown.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as biomet product was not involved in the event.

• Brand Name: UNK PLATE
• Type of Device: APPLIANCE, 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: 4562148
• MDR Text Key: 20785663
• Report Number: 0001825034-2015-00780
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 74