MAUDE Adverse Event Report: BIOMET MICROFIXATION MODIFIED BECK ELEVATOR; PERIOSTEAL ELEVATOR, REUSABLE

Catalog Number	SP-2359
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 was reported that the tip of the elevator was fractured during a procedure with no patient injury or procedural delay.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h4, h6, h11.A visual inspection was conducted on the returned elevator.The elevator shows signs of multiple uses including heavy marking and scratching on the product surface.Further inspection shows that the elevator tip has fractured.The fractured portion of the tip was not returned.The returned device was reviewed with scanning electron microscopy.Sem images identified ductile dimples on the fracture surface, suggesting the overload failure mode.Analysis found the device material to be consistent with 304 stainless steel alloy.The complaint is confirmed.Review of the dhr identified no deviations or anomalies.A supplier dhr review was not performed as product has approximate field age of 1 year, with an unknown number of uses.Visual inspection shows signs of multiple uses included marking/ scratching on the product surface.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: MODIFIED BECK ELEVATOR
• Common Device Name: PERIOSTEAL ELEVATOR, REUSABLE
• 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: 21560237
• Report Number: 0001032347-2025-00115
• Device Sequence Number: 4430929
• Product Code: EMJ
• UDI-Device Identifier: 00841036285302
• UDI-Public: (01)00841036285302(10)00385640
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: SP-2359
• Device Lot Number: 00385640
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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