MAUDE Adverse Event Report: BIOMET MICROFIXATION MODIFIED BECK ELEVATOR; ELEVATOR, SURGICAL, DENTAL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the instrument fractured at the tip during surgery.There were no consequences or impact to the patient.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.
Event or Problem Description
It was further reported that no part of the fractured instrument fell into the patient.There was no injury or delay in surgery.The surgery was completed with a back-up instrument.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned elevator.The elevator shows signs of multiple uses including marking and scratching on the elevator surface.Further inspection showed that the elevator tip has fractured.The fractured portion of the tip was not returned.A fracture analysis was not conducted as the fracture is indicative of the use of the product as supplier dhr review confirmed that product was conforming prior to being shipped.A determination cannot be made as to what caused the fracture to occur.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed, based on evaluation of the returned product.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 is available at the time of this report.

• Brand Name: MODIFIED BECK ELEVATOR
• Common Device Name: ELEVATOR, SURGICAL, DENTAL
• 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: 19405336
• Report Number: 0001032347-2024-00168
• Device Sequence Number: 6786729
• Product Code: EMJ
• UDI-Device Identifier: 00841036285302
• UDI-Public: (01)00841036285302(10)D23
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2024

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: SP-2359
• Device Lot Number: D23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 05/30/2024; 08/02/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/26/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown