MAUDE Adverse Event Report: BIOMET MICROFIXATION SCRW 2.4X16MM CANCELOUS LOCKNG; STERNALOCK BLU SYSTEM SCREW

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

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 the screw fractured during insertion into the patient's sternum.The surgeon used forceps to remove the fractured screw.There were no consequences or impact to the patient.The procedure was completed with another screw in a different location.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This report is being submitted to update additional information in sections a3, b4, b5, b7, d9, g3, g6, h2, h6, and h11.

Event Description

It was further reported that a fragment of the screw was retained by the patient after attempts to remove the screw by the surgeon using forceps failed.The majority of the fractured screw was removed, but a piece of the fractured screw remained in the patient's bone.The procedure was completed with another screw being inserted in a different location.

• Brand Name: SCRW 2.4X16MM CANCELOUS LOCKNG
• Type of Device: STERNALOCK BLU SYSTEM SCREW
• 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: 18968011
• MDR Text Key: 338481832
• Report Number: 0001032347-2024-00100
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• 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): Other
• Patient Sex: Male