MAUDE Adverse Event Report: BIOMET ORTHOPEDICS AGC V/2 QUICK RELEASE DRL BITS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 04/23/2015

Event Type  Injury  

Event Description

It was reported that patient underwent an initial left partial knee arthroplasty on (b)(6) 2015.During the procedure, the drill pin fractured while removing the tibial guide from the patient's bone.The surgeon was unable to remove the fractured portion of the drill pin and it remains in the patient's bone.

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 damage or deformed material at the chuck end of the drill bit.This damage could have been caused by a variety of reasons including the drill bit hitting something too hard to drill through, the drill bit binding up quickly causing the material to deform, or excessive force being used.

• Brand Name: AGC V/2 QUICK RELEASE DRL BITS
• 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: 4787711
• MDR Text Key: 5798886
• Report Number: 0001825034-2015-02124
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• 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: 32-467619
• Device Lot Number: 110784
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2005
• 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): Disability