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

Model Number N/A

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 05/04/2022

Event Type  Injury  

Event 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.

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 Description

No further event information available at the time of this report.

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 Description

No further event information available at the time of this report.

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
• Type of Device: 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
• MDR Text Key: 293653160
• Report Number: 0001032347-2022-00194
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036126605
• UDI-Public: (01)00841036126605(10)442530
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K063052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female