MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM CROSS DRIVE SCREW

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).A2: dob: (b)(6), as both dates provided the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient was revised due to a surgical site infection.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was further reported that the plates were removed under general anesthesia and the third molars in the fracture line were extracted.There were no intra-operative complications or events.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected: b3; d6 the following sections were updated:.

Event Description

The reported event of infection is not considered a serious injury as it is not device related.This is a non-sterile product related infection and is not considered a zimmer biomet issue as it is labeled as non-sterile and presumed to be sterilized and readied elsewhere; therefore, products are not identified as the source or contributing to the reported infection.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.G2: foreign - argentina.The following sections were corrected: d2 - device product code and common device name.

Event Description

No further event information available at the time of this report.

• Brand Name: 2.0MM CROSS DRIVE SCREW
• Type of Device: 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: 18268302
• MDR Text Key: 329741607
• Report Number: 0001032347-2023-00455
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 95-2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/08/2023; 12/14/2023; 02/15/2024
• Supplement Dates FDA Received: 01/03/2024; 01/11/2024; 02/19/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 80 KG