MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DRILL BIT FAST 2.0MM; DRILL, BIT

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Operating System Becomes Nonfunctional (2996)

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

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.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 a patient underwent an internal fixation procedure on (b)(6) 2015.During the procedure, the drill bit froze and locked into the plate, resulting in the drill bit fracturing off into the plate.The plate and screws were removed and a new plate was used to complete the procedure.

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.Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition.Root cause of the event was most likely attributed to surgical technique.There are warnings in the package insert that state that this type of event can occur: under precautions, it states, "intraoperative fracture or breaking of instruments has been reported for general instruments." under care and handling of instruments, it states, ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.¿.

Manufacturer Narrative

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

Event Description

It was reported a patient underwent an internal fixation procedure on (b)(6) 2015.During the procedure, the drill bit froze and locked into the plate, resulting in the drill bit fracturing off into the plate.The plate and screws were removed and a new plate was used to complete the procedure.There was a one hour delay in procedure.

• Brand Name: DRILL BIT FAST 2.0MM
• Type of Device: DRILL, BIT
• 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: 5254516
• MDR Text Key: 32296065
• Report Number: 0001825034-2015-04802
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• 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: FDB20
• Device Lot Number: 650807008
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 71 YR