MAUDE Adverse Event Report: BIOMET MICROFIXATION T15 HEXALOBE DRIVER SILVER; DRIVER, PROSTHESIS

Model Number 201.047.15

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a cabg procedure, a torque limiter was not placed on the drill and the tip of the screw blade broke off and was later discovered to be left in the patient.The procedure was completed as planned and it was not noted until days later that the blade had fractured.There was no medical intervention and it was deemed that the risk of removing the broken piece was a higher risk than to leave it inside the patient.It was reported that no further information is available.

• Brand Name: T15 HEXALOBE DRIVER SILVER
• Type of Device: DRIVER, PROSTHESIS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18878122
• MDR Text Key: 337409459
• Report Number: 0001032347-2024-00093
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 201.047.15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Male