MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN TRAUMA; ROD, FIXATION

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Align (2522)

Patient Problem No Information (3190)

Event Date 01/09/2015

Event Type  Injury  

Event Description

It was reported that patient underwent an internal fixation procedure on (b)(6) 2015.During the procedure, a complication occurred in which the lag screw drill was drilling into metal.It was noticed that when a member of the staff was trying to assemble the selected nail onto the jig he was using the end cap driver, which was incorrect, and he was instructed to change to the jig bolt driver.The scrubbed odp was instructed to check the alignment of the assembly related to the jig and nail by placing the lag screw sleeve and instruments through the correlating holes.After the nail was implanted, the surgeons struggled to place the lag screw wire.Then, while engaging the nail the lag screw drill was drilling into metal.After removing the nail, it was evident that the internal set screw had been driven downward into the path of the lag screw hole where the lag screw was drilling through.As a result of this complication, there was a 20 minute delay in surgery.The nail in question was removed and a new one was implanted.After the procedure, it was concluded that there was an error in the operating room during the assembly.

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.Brand name - unknown.Device type - unknown.Device information - unknown.Pma/510(k) number - unknown.Manufacture date ¿ unknown.

• Brand Name: UNKNOWN TRAUMA
• Type of Device: ROD, 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: 4772703
• MDR Text Key: 21089005
• Report Number: 0001825034-2015-02046
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 05/14/2015
• 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): Required Intervention