MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF UNI FEMORAL DRILL 6.35; PROSTHESIS, KNEE

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

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: expiration date - unknown.Manufacture date ¿ unknown.Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.

Event Description

It was reported that patient underwent a partial knee procedure on (b)(6) 2015.During the procedure, the drilling was not smooth due to patient's hard bone; therefore, the drill was pressed during drilling.Subsequently, the drill fractured and pieces had to be retrieved from the patient.A tap was used to complete the procedure.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.During the evaluation, the drill bit showed evidence of fracture.Root cause of the event was most likely attributed to the combination of the drill bit becoming dull and not cutting properly and the patient's bone hardness.There are warnings in the package insert that state that this type of event can occur: under precautions, number 1 states, "intraoperative fracture or breaking of instruments has been reported for general instruments." number 3 states, "surgical instruments are subject to wear with normal usage.Instruments with cutting functions or points may become dull with normal use and no longer perform as intended.Inspect prior to use to verify the cutting ability and sharpness of edges." number 4 states, "instruments that have experienced extensive use or excessive force are susceptible to fracture.".

• Brand Name: OXF UNI FEMORAL DRILL 6.35
• Type of Device: PROSTHESIS, KNEE
• 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: 5363620
• MDR Text Key: 35787421
• Report Number: 0001825034-2016-00143
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2016

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: 32-422845
• Device Lot Number: ZB120701
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/13/2016
• Supplement Dates Manufacturer Received: 03/08/2016; 03/08/2016
• Supplement Dates FDA Received: 02/01/2016; 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention