MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF MP SLOT POST CUT GD MED; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 12/22/2014

Event Type  Injury  

Event Description

It was reported patient underwent a partial knee arthroplasty on (b)(6) 2014.During the procedure, the peg fractured in the patient while utilizing the extractor to remove the guide.All fractured fragments were removed from the patient.

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

Manufacturer Narrative

Evaluation of device found evidence that failure mode was due to bending overload.Review of dhr and inspection records show that the instrument was manufactured in jan 2014 with no noted nonconformities.It is possible that the instrument was damaged in a prior procedure and weakened the weld causing the current fracture.Instrument was damaged and used beyond useful life.

• Brand Name: OXF MP SLOT POST CUT GD MED
• 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: 4424192
• MDR Text Key: 5277229
• Report Number: 0001825034-2015-00199
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• 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: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• 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: 32-422981
• Device Lot Number: ZB140102
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• 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
• Patient Age: 65 YR