MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 301 APEXO ELEVATOR

Model Number	E301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during two separate dental patient procedures the tip of a 301 apexo elevator broke off in the patient's mouth.For the first patient, the tip went into the sinus and required an additional procedure to retrieve the broken part.The tip was immediately retrieved from the second patient's mouth.All components were successfully retrieved in both cases.
Additional Manufacturer Narrative
The two devices subject of the events were returned to hufriedy for evaluation.One of the devices (y9) was manufactured in november 2009 and there was evidence of corrosion on the device and the handle was worn.The other device (120) was manufactured in january 2020 and the handle had visible abrasions.Each device was observed under magnification at the breakage point.The surfaces at the breakage point had indications of overload failure.The hufriedy instrument reprocessing guide includes the following language related to inspection of instruments when reprocessing (3.2), "inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not further use damaged instruments (for limitation of the numbers of re-use cycles, see 3.8 reusability section).If instruments are still visibly soiled, clean again.Re-sharpen instruments if necessary.Completely remove any residues from the sharpening process, such as metal residue or sharpening oil.In case sharpening is done, remember to repeat the cleaning and sterilization process." the instrument reprocessing guide further states (3.3), "light corrosion on the surface can be removed with hu-friedy penetrating oil (ips) or shine renew (ims-1455).If the corrosion cannot be completely eliminated, the instruments should be removed from use.Otherwise such corrosion could damage other instruments.After treating an instrument with shine renew or ips, the instrument must be cleaned and sterilized once more." hufriedy has contacted the customer for additional information including how the instruments were being used.To date, we have not received a response.A follow-up mdr will be submitted should additional information become available.

• Brand Name: 301 APEXO ELEVATOR
• Common Device Name: ELEVATOR
• 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: daniel davy ; 3232 n rockwell st.; chicago, IL 60618 ; 4403927453
• MDR Report Key: 16911343
• Report Number: 1416605-2023-00003
• Device Sequence Number: 12266300
• Product Code: EMJ
• UDI-Device Identifier: 10889950009083
• UDI-Public: 10889950009083
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: E301
• Device Catalogue Number: E301
• Device Lot Number: Y9, 120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2009
• 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
• Patient Sex: Unknown