MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical products: item#: 76-2410, lot#: unknown, ribfix blu scr s/d-lk 2.4x10mm qty 2.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00144, 0001032347-2022-00145.

Event Description

It was reported that the patient was revised due to do migration as the plate and two screws were seen lifted away from the bone on an x-ray.The surgeon indicated that there were technical issues during implantation.Attempts have been made and additional information is not available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A photo was provided, which shows the explanted devices.The photo shows the explanted plate is fractured.The complainant reported the plate was not fractured on the original scan, but was elevated off the bone.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.It was reported the surgeon indicated that there were technical issues during implantation, however, no additional information was provided regarding these issues and no medical records were provided.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.

Event Description

No further event detail is available at the time of this report.

• Brand Name: RIBFIX BLU SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 14428125
• MDR Text Key: 291934080
• Report Number: 0001032347-2022-00143
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• 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: SP-3311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male