MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM PLATE CURVED 6 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	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that about one year after the initial surgery, the implanted plate was found to be broken.It is further reported that the patient has not yet been revised.The patient has been discharged and will have a recheck.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10 ¿ medical products: item# 01-9226, lot # 354380; "2.0mm" system plate curved 6 hole med.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 on both plates.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 health care professional.Review of the available image identified the following: the single image presented for review demonstrates two fractured malleable plate and screw fixation devices.No other concerns with the implants or bony/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 which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00426.

• Brand Name: 2.0MM SYSTEM PLATE CURVED 6 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: 18161462
• Report Number: 0001032347-2023-00425
• Device Sequence Number: 6503959
• Product Code: JEY
• UDI-Device Identifier: 00841036017149
• UDI-Public: (01)00841036017149(10)354380
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-9226
• Device Lot Number: 354380
• 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: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SE H10
• Patient Sex: Unknown