MAUDE Adverse Event Report: BIOMET TRAUMA T7 DRIVER CANNULATED AO; INSTRUMENT, MANUAL

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.Examination of manufacturing history found no evidence of product non-conformance and device likely left the manufacturer conforming to print.Visual inspection of the drivers confirms both are deformed at the distal tip; however, the driver tip twisting is an intentional part of the driver's design.The twisting prevents the screw head from fracturing or stripping.A conclusive root cause of the event could not be determined with the available information; however, the most likely root cause was application of torque higher than the driver is designed to withstand.There are warnings in the package insert that state that this type of event can occur: 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.Care must be taken to avoid compromising their exacting performance." under precautions, it states, "biomet recommends that all instruments be regularly inspected for wear and disfigurement prior to use.".

Event Description

During a first metatarsal osteotomy procedure, two cannulated drivers stripped.The drivers were used to complete the procedure without patient injury or delay.

• Brand Name: T7 DRIVER CANNULATED AO
• Type of Device: INSTRUMENT, MANUAL
• Manufacturer (Section D): BIOMET TRAUMA; 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: 6026403
• MDR Text Key: 57316423
• Report Number: 0001825034-2016-04116
• Device Sequence Number: 1
• Product Code: MDM
• 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
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110018531
• Device Lot Number: 13869A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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 Age: 23 YR