MAUDE Adverse Event Report: BIOMET TRAUMA ORTHOSORB LS 1.3MM 3 PIN KIT; PIN, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states, ¿bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing.¿.

Event Description

It was reported that patient underwent an unknown procedure on an unknown date.Subsequently, a revision procedure has been indicated due to fracturing pins; however, no revision has been reported at this time.No further information has been provided.

• Brand Name: ORTHOSORB LS 1.3MM 3 PIN KIT
• Type of Device: PIN, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5273572
• MDR Text Key: 32895997
• Report Number: 0001825034-2015-04912
• Device Sequence Number: 1
• Product Code: OVZ
• Combination Product (y/n): N
• PMA/PMN Number: PK140625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• 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: 110010742
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2015
• 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