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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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 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

During an unknown procedure the pin fractured.No patient injury or delay was reported.

• 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 ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5792505
• MDR Text Key: 49499028
• Report Number: 0001825034-2016-02575
• Device Sequence Number: 1
• Product Code: OVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/26/2021
• Device Model Number: N/A
• Device Catalogue Number: 110010742
• Device Lot Number: 172230
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1