MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 12 HOLE STRAIGHT 2.0MM PLATE; CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE

Model Number	N/A
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery due to implant fracture approximately four (4) years after implantation.It was reported that no further information is available.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Medical product - zimmer biomet screw catalog#: 41-2106 lot#: 738570 (qty 1), zimmer biomet screw catalog#: 41-2412 lot#: 406480 (qty 5), zimmer biomet screw catalog#: 41-2708 lot#: 438490 (qty 2), zimmer biomet screw catalog#: 41-2712 lot#: 045290 (qty 1).Report source - foreign - (b)(6).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
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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 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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available images identified the following: right-sided plate and screw fixation is present.There is a fracture of the right mandibular fixation plate without displacement.There is no evidence of trauma or injury.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: TRAUMAONE SYSTEM 12 HOLE STRAIGHT 2.0MM PLATE
• Common Device Name: CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE
• 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: 14631638
• Report Number: 0001032347-2022-00194
• Device Sequence Number: 5901108
• Product Code: JEY
• UDI-Device Identifier: 00841036126605
• UDI-Public: (01)00841036126605(10)442530
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2022

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: 44-1012
• Device Lot Number: 442530
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 08/05/2022; 09/09/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/18/2022; 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2017
• 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: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female