MAUDE Adverse Event Report: BIOMET MICROFIXATION EXODONTIA ELEVATOR #81; PERIOSTEAL ELEVATOR, REUSABLE

Catalog Number	09-0293
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the elevator was discovered to be worn over time and needed replacing.No specific surgery or patient was involved, and no patient harm was reported.Investigation of the returned device has concluded that the instrument has a fractured tip.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: crane pick elevator cat# 09-0262 lot# k20.Crane pick elevator cat# 09-0262 lot# k20.Crane pick elevator cat# 09-0262 lot# d22.Crane pick elevator cat# 09-0262 lot# k21.Crane pick elevator cat# 09-0262 lot# k21.Crane pick elevator cat# 09-0262 lot# j20.Elevator #77r cat# 09-0313 lot# g22.Elevator #77r cat# 09-0313 lot# g22.Elevator #77r cat# 09-0313 lot# b21.Elevator #77r cat# 09-0313 lot# l19.Elevator #77r cat# 09-0313 lot# l19.Elevator #77r cat# 09-0313 lot# d19.Elevator #77r cat# 09-0313 lot# d19.Elevator #77r cat# 09-0313 lot# f19.Exodontia elevator #81 cat# 09-0293 lot# h19.Exodontia elevator #81 cat# 09-0293 lot# c18.Molt periosteal elevator #9 cat# 09-0394 lot# g19.Molt periosteal elevator #9 cat# 09-0394 lot# g19.Molt periosteal elevator #9 cat# 09-0394 lot# g19.Molt periosteal elevator #9 cat# 09-0394 lot# j21.Elevator #1 cat# 09-0259 lot# c19.A visual investigation was conducted on the returned instrument.The instrument shows signs of multiple uses including very heavy marking and scratching on the instrument surfaces.Further inspection shows that the elevator tip has fractured.The fractured tip was not returned.A determination cannot be made as to what caused the elevator to fracture.A fracture analysis was not conducted as the instrument shows signs of multiple uses.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed through 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 ELEVATOR #81
• 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: 23819254
• Report Number: 0001032347-2025-00475
• Device Sequence Number: 21184529
• Product Code: EMJ
• UDI-Device Identifier: 00841036028466
• UDI-Public: (01)00841036028466(10)032018C18
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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: 09-0293
• Device Lot Number: C18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2018
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown