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

Model Number E301

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 315001250
• Report Number: 1416605-2023-00003
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 10889950009083
• UDI-Public: 10889950009083
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1