MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DVR ANATOMIC NARW SHORT RIGHT; APPLIANCE, FIXATION

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/11/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a right distal radius orif surgery on (b)(6) 2015.During the surgery, the threads of the dvr plate would not engage with the threaded portion of the pegs.Another plate in the set was used to complete the procedure.The same pegs were used with the second plate.

Manufacturer Narrative

Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted that the root cause of the event was most likely due to improper surgical technique and/or misuse, by product being put through excessive force which may have prevented the use of the product and contributed to its failure.

• Brand Name: DVR ANATOMIC NARW SHORT RIGHT
• 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: 4612835
• MDR Text Key: 18295838
• Report Number: 0001825034-2015-01066
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

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: DVRANSR
• Device Lot Number: RM526E
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 03/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2014
• 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
• Patient Outcome(s): Required Intervention