MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM PLATE 2.0/1.0 4 HOLE MED; PLATE, BONE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Foreign: china.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a orthognathic procedure, and subsequently was revised due to the plate being fractured.The fracture was detected on x-ray during an outpatient review.The patient's intra-oral occlusion was examined to be altered to the immediate postoperative period, and it was proposed that the patient be admitted to the hospital for a revisions procedure to fix and adjust the mandibular position.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned items.The inspection showed signs of use including marking and scratching on both the plates and the screws.The complaint was for a total of one 01-9288 plate.The review shows that one of the plates has fractured at one of the screw hole sections.The complaint for this item is confirmed.The other items that were returned were a part of the surgery, but no defect was reported.Visual inspection of these items showed no issues.The fractured plate was inspected with a scanning electron microscope.Suspected fatigue striations were identified along with smeared surface regions.There were no indications of overload fracture that are typically observed in cp-ti material, such as ductile dimples, and the identified artifacts suggest a low-cycle bending fatigue failure mode.Eds semi-quantitative elemental analysis found the plate sample material to be consistent with cp-ti composition, along with contamination (e.G., carbon and oxygen).A definitive root cause cannot be determined.The reported event is confirmed, based on the x-ray provided and product return.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.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h6 and h10.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned items.The inspection showed signs of use including marking and scratching on both the plates and the screws.The complaint was for a total of one 01-9288 plate.The review shows that one of the plates has fractured at one of the screw hole sections.The complaint for this item is confirmed.The other items that were returned were a part of the surgery, but no defect was reported.Visual inspection of these items showed no issues.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a single panorex image demonstrates postsurgical changes of the bilateral maxilla and mandible.Fractured malleable plate and screw device involving the body of the right mandible.No other implant or anatomical concerns that would lead to a revision were identified.A definitive root cause cannot be determined.The reported event is confirmed, based on the x-ray provided and product return.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.This report is being submitted to update additional information in sections b4, b5, d9, g3, g6, h2, h3, h6 and h10.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 2.0MM SYSTEM PLATE 2.0/1.0 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: 17297970
• Report Number: 0001032347-2023-00277
• Device Sequence Number: 19802057
• Product Code: JEY
• UDI-Device Identifier: 00841036017538
• UDI-Public: (01)00841036017538(10)032240
• 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,Followup,Followup
• Report Date (Section B): 12/21/2023

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: 032340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 10/30/2023; 12/20/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 11/03/2023; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female