MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMA ONE SYSTEM 2.0; SCREW, FIXATION, INTRAOSSEOUS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The following sections could not be completed because part/lot information could be: 2.0 x 7mm sd imf hex screw.Catalog number: 91-5607.Lot number: ni.Manufacture date: ni.Or the part/lot information could be: 2.0 x 9mm sd imf hex screw.Catalog number: 91-5609.Lot number: ni.Manufacture date: ni.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 is reported that the screw fractured at bone level during implantation.The fractured piece remains implanted between teeth 43 and 44.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It has further been reported by the surgeon that the product involved in this case was a competitor's product and not a zimmer biomet product.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, d1, d2, d3, d4, g3, g6, h1, h2, h3, h6 and h10.Upon reassessment of the reported event based on additional information.The product that contributed to the reported event was not zimmer biomet product, but rather a competitor's product.This initial report submitted needs to be voided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TRAUMA ONE SYSTEM 2.0
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• 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: 15580801
• MDR Text Key: 301553100
• Report Number: 0001032347-2022-00322
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K983728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2022
• 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