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

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Date 12/24/2015

Event Type  Injury  

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.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.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, number 1 states, ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.¿.

Event Description

It was reported that patient underwent right partial knee arthroplasty on (b)(6) 2015.During the procedure, the drill bit fractured.As a result, the surgeon used a drill of a smaller size and then expanded the hole with an awl.The surgeon then completed making the hole with the drill bit that had previously fractured.This resulted in a delay of approximately sixty (60) minutes.

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

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 instrument showed evidence of fracture.Root cause of the event was most likely attributed to the instrument being dull causing the surgeon to use excessive force; however, a conclusive root cause could not be determined.

• Brand Name: OXF UNI FEMORAL DRILL 6.35
• Type of Device: BIT, DRILL
• 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: 5356663
• MDR Text Key: 35531421
• Report Number: 0001825034-2016-00106
• 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: 03/09/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/12/2016; 03/31/2016
• Was Device Evaluated by Manufacturer?: No
• 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: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other