MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC HU-FRIEDY; ELEVATOR, DENTAL

Model Number	EHB13/14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to hu-friedy for evaluation, and it was found that the left tip was broken and showed signs of oxidation.The oxidized surface indicates the device was likely previously damaged or cracked before it was subsequently strained beyond its capabilities by use of excessive force.The hu-friedy instrument reprocessing guide states hu-friedy's reprocessing guide states "3.2 inspection"; "inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not further use damaged instruments." no manufacturing defects were found.
Event or Problem Description
User facility reported that the tip broke and ended up in patient's nasal cavity.The doctor was unable to remove it.The patient went to er and was put on antibiotics.Patient will be reevaluated in 2 weeks.

• Brand Name: HU-FRIEDY
• Common Device Name: ELEVATOR, DENTAL
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n. rockwell st.; chicago IL 60618
• Manufacturer Contact: stephanie wasielewski ; 1666 e. touhy ave.; des plaines, IL 60018 ; 8472574500
• MDR Report Key: 20694530
• Report Number: 1416605-2024-00012
• Device Sequence Number: 3782647
• Product Code: EMJ
• UDI-Device Identifier: 10889950009779
• UDI-Public: (01)10889950009779
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EHB13/14
• Device Catalogue Number: EHB13/14
• Device Lot Number: 0423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Sex: Female