MAUDE Adverse Event Report: BIOMET MICROFIXATION EXODONTIA ELEVR #46R SERRATED; ELEVATOR, SURGICAL, DENTAL

Catalog Number	09-0252
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint (b)(4).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 is reported that the tip of instrument was fractured.There was no patient harm and this did not occur during a surgery.
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.The following sections were updated/corrected: b4, b5, d9, g3, g6, h2, h3, h4, h6, h11 a visual inspection was conducted on the two returned elevators.Both elevators show signs of multiple uses including heavy marking and scratching on the elevator surface.Further inspection shows that both elevators have fractured.The complaint is confirmed on both elevators.A fracture analysis was not conducted as the fracture is indicative of the use of the product as dhr review confirmed that product was conforming prior to being shipped.A determination cannot be made as to what caused the elevators to fracture.Review of the dhr identified no deviations or anomalies.A supplier dhr review was not performed as products have approximate field ages of 1 and 2 years, with an unknown number of uses.Visual inspection shows signs of multiple uses included marking/ scratching on the product surface and there is no indication that a manufacturing deficiency occurred.Harm severity 1/2 non-reportable.A definitive root cause cannot be determined.The reported event is confirmed, based on product return.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: EXODONTIA ELEVR #46R SERRATED
• 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: 21713054
• Report Number: 0001032347-2025-00179
• Device Sequence Number: 4745444
• Product Code: EMJ
• UDI-Device Identifier: 00841036028152
• UDI-Public: (01)00841036028152(10)B23
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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
• Device Catalogue Number: 09-0252
• Device Lot Number: B 23
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 07/24/2025
• Date Device Manufactured: 11/10/2022
• 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