MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DVR EPAK NRW LOCK PLT R; PLATE, FIXATION

Model Number N/A

Device Problem Component Missing (2306)

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

Event Date 12/16/2014

Event Type  malfunction  

Event Description

It was reported that the patient underwent an internal fixation procedure on (b)(6) 2014.During the procedure, it was noted that the e-pak was missing one 16 mm screw.Another screw was utilized to complete the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch and to correct information that was reported on a previous medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Received investigation results from the supplier regarding this complaint.In summary, no issues were found and the correct amount of screws were counted and confirmed on two separate occasions.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

It was reported that the patient underwent an internal fixation procedure on an unknown date.During the procedure, it was noted that the e-pak was missing one 16 mm screw.Another screw was utilized to complete the procedure.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.The following sections could not be completed with the limited information provided.Date of event - unknown.

• Brand Name: DVR EPAK NRW LOCK PLT R
• Type of Device: PLATE, 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: 4400584
• MDR Text Key: 5502975
• Report Number: 0001825034-2015-00102
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 811811050
• Device Lot Number: 269330
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2014
• 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