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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 12/28/2023

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).D4: catalog number - part number is either 76-2603 or 76-2602.D10: medical product - zimmer biomet ribfix blu 16 hole prebent plate catalog #: 76-2603 lot#: unknown; zimmer biomet ribfix blu 12 hole prebent plate catalog #: 76-2602 lot #: unknown; zimmer biomet ribfix blu 10 mm screw catalog #: 76-2410 lot #: unknown; zimmer biomet ribfix blu 8 mm screw catalog #: 76-2408 lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent surgery to repair two fractured ribs approximately three months ago.Subsequently, the patient had a severe cough and the plate fractured causing discomfort.The patient underwent a revision to remove the fractured plate approximately 1 month ago.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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.

Event Description

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

• Brand Name: UNKNOWN RIBFIX BLU PLATE
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18606820
• MDR Text Key: 334100964
• Report Number: 0001032347-2024-00032
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162974
• 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
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization