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

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

Review of device history records show that lot released with no recorded anomaly or deviation.Examination of returned device found no evidence of product non-conformance and confirmed reported condition.The driver tip twisting is intentionally designed in order to prevent damage to the screw.Root cause is likely application of a torque higher than the driver was designed to withstand; however, a conclusive root cause of the event could not be determined.

Event Description

During a procedure, the screw driver head warped while inserting a screw.Another driver was used to complete the procedure without delay.

• Brand Name: T7 DRIVER CANN 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: 5718554
• MDR Text Key: 47200771
• Report Number: 0001825034-2016-02033
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• 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: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2016
• 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