MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DVR EPAK MEDIUM LOCK PLT L; APPLIANCE, FIXATION

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/17/2014

Event Type  Injury  

Event Description

It was reported that patient underwent an open reduction and internal fixation (orif) of a distal radius fracture case on (b)(6) 2014.During the procedure, the surgeon attempted to implant a cortical locking screw in the second most radial hole of the plate; however, the screw would not lock and continued to spin in the hole.The surgeon attempted a shorter screw without success and opted to leave the hole unfilled.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of deviation history records show that lot released with no recorded anomaly.The complained device is implanted and is not available for evaluation.In the event that more information is received, a follow up report will be sent to the fda.(b)(6).

Manufacturer Narrative

This follow-up report is being filed to correct information that was reported on a previous medwatch.

• Brand Name: DVR EPAK MEDIUM LOCK PLT L
• Type of Device: APPLIANCE, 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: 4330923
• MDR Text Key: 5132486
• Report Number: 0001825034-2014-09142
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2015

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 Expiration Date: 11/15/2018
• Device Model Number: N/A
• Device Catalogue Number: 811822060
• Device Lot Number: 187157
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2013
• 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): Disability