MAUDE Adverse Event Report: BIOMET MICROFIXATION CRANE PICK 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 is reported that the elevator fractured during a procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: d4, d9.The following sections were updated: b4, b5, d10, g3, g6, h2, h3, h4, h6, h10, h11.D10: elevator #0 cat# 09-0258 lot#d15.Elevator #0 cat# 09-0258 lot#l12.Elevator #0 cat# 09-0258 lot#c13.Crane pick elevator cat# 09-0262 lot# 00376350.For the reported two 09-0262 lots 00376350 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Item# 09-0262 lot# 00376350- review of the device history record(s) identified no deviations or anomalies during manufacturing.A supplier dhr review was not requested as the instrument has an estimated field age of three years of use.Product was 100% inspected and there were no visual anomalies.A definitive root cause cannot be determined.Item# 09-0262 lot# 00376350- the reported event is unconfirmed.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: CRANE PICK 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: 21155026
• Report Number: 0001032347-2025-00014
• Device Sequence Number: 9089020
• Product Code: EMJ
• UDI-Device Identifier: 00841036028237
• UDI-Public: (01)00841036028237(10)00376350
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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 Model Number: N/A
• Device Catalogue Number: 09-0262
• Device Lot Number: 00376350
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown