MAUDE Adverse Event Report: BIOMET MICROFIXATION PERIOSTEAL ELEVATOR #9; ELEVATOR, SURGICAL, DENTAL

Catalog Number	09-0388
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign - costa rica.The device will not be returned as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the instrument used to loosen the periosteum had the tip of the instrument crack and fracture off.There was no harm to the patient as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: a1, a2, a3, b5, b7, e1, g3, h1, h2, and h11.
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.The reported event was confirmed by review of pictures.No product was returned.A visual inspection was conducted on the customer provided pictures.The pictures show signs of multiple uses including heavy marking and scratching on the instrument surface.Further inspection shows that the elevator has fracture at the base of the tip.The complaint is confirmed.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Attempts have been made and no further information has been provided.

• Brand Name: PERIOSTEAL ELEVATOR #9
• 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: 22884862
• Report Number: 0001032347-2025-00351
• Device Sequence Number: 17372248
• Product Code: EMJ
• UDI-Device Identifier: 00841036029142
• UDI-Public: (01)00841036029142(10)011516A16
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

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: 09-0388
• Device Lot Number: A16
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/26/2025; 12/30/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/30/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2016
• 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 Age: 16 YR
• Patient Sex: Male