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

Model Number N/A

Device Problems Difficult to Insert (1316); Mechanics Altered (2984)

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

Event Date 10/22/2014

Event Type  malfunction  

Event Description

It was reported patient underwent a fracture reduction procedure on (b)(6) 2014.During the procedure, it was noted a screw from the e-pak was round and not tetragonal and it was not possible to insert the screw into the blind hole.Another screw from the e-pak was utilized to complete the procedure.

Manufacturer Narrative

Examination of returned device found evidence of product non-conformance.A supplier corrective action request has been initiated.Initial reporter phone : (b)(4).

• Brand Name: DVR EPAK 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: 4469603
• MDR Text Key: 5187935
• Report Number: 0001825034-2015-00411
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK112345
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 811812050
• Device Lot Number: 199658
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• 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