MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 16 HOLE STRAIGHT 1.6MM PLATE; BONE PLATE

Catalog Number	43-1016
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: associated product information, part (lot): unknown screws (unknown).G2: foreign - the event occurred in india.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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 or Problem Description
It was reported that approximately three (3) weeks after an oral cranio-maxillofacial fixation procedure, the patient underwent a revision due to implant fracture.The implanted plate was fractured in two (2) parts and removed.New plating and screws were implanted during the revision procedure.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event is confirmed, based on provided photos.No product was returned.A visual inspection was conducted on the customer provided pictures.The pictures show that the plate has clearly fractured.The complaint is confirmed.A determination cannot be made as to what caused the plate to fracture.A review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a healthcare professional.A review of the available records identified the following: plate and screw fixation is present at the left side of the mandible with bone grafting.The fixation plate is fractured laterally, and there is displacement of the lateral bone graft without incorporation.The implants do not appear loose.Bone quality is osteopenic.A definitive root cause cannot be determined.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 or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: d9; g3; h2; h3; h4; h6; h11.Complaint sample was evaluated, and the reported event was confirmed.A visual inspection was conducted on the returned plate.The plate shows signs of attempted use including heavy marking and scratching on the plate surface.Further inspection shows that the plate has fractured.Only 1 piece of the fractured plate was returned.Fracture analysis and the returned device was examined using optical microscopy and scanning electron microscopy.Suspected fracture initiation site was identified where fatigue striations were observed and the direction of crack propagation was determined.These observations suggest that the primary fracture mode was fatigue, initiating near the corner of the inner, bone-contacting surface.Elemental analysis confirmed that the composition of the specimen is consistent with commercially pure titanium (cp ti).For clarity, carbon and oxygen¿likely originating from surface contamination¿were excluded from the reported results.Trace amounts of silicon (si), calcium (ca), and gallium (ga) were also detected and are similarly considered to be surface contaminants.Root cause remains unchanged and cannot be determined.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.

• Brand Name: TRAUMAONE SYSTEM 16 HOLE STRAIGHT 1.6MM PLATE
• Common Device Name: BONE PLATE
• 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: 21316044
• Report Number: 0001032347-2025-00075
• Device Sequence Number: 18255836
• Product Code: JEY
• UDI-Device Identifier: 00888233008884
• UDI-Public: (01)00888233008884(10)058260
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K113512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 06/30/2025

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: Lay User/Patient
• Device Catalogue Number: 43-1016
• Device Lot Number: 058260
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 06/17/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/18/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 100 KG