MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM PLATE 4 HOLE MED; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).G2: foreign source: china.No product was returned.A visual inspection was conducted on the customer-provided x-ray.The x-ray shows a clear fracture of the plate pointed out by the yellow arrow in the picture.The complaint is confirmed.A determination cannot be made as to what caused the plate to fracture.Review of the device history records identified no deviations or anomalies during manufacturing.A radiograph was provided and reviewed by a healthcare professional.A review of the available image identified the following: the single panorex image demonstrates multiple malleable plate and screw devices within the mandible with fractured plate along the posterior left molars.No other concerns were identified with the implants, such as alignment, placement, or loosening.No bony or anatomical concerns were identified.A definitive root cause cannot be determined.The reported event is confirmed, based on the provided x-ray.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that after the initial surgery, the implant fractured and the patient was revised.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 2.0MM SYSTEM PLATE 4 HOLE MED
• Common Device Name: PLATE, 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: 18192309
• Report Number: 0001032347-2023-00427
• Device Sequence Number: 15257707
• Product Code: JEY
• UDI-Device Identifier: 00841036017538
• UDI-Public: (01)00841036017538(10)989990
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-9288
• Device Lot Number: 989990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown