MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC PERIOTOME

Model Number	PT1X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported a part of their periotome detached in the patient's mouth during a dental procedure.It was reported that the patient was sent to receive x-rays.
Additional Manufacturer Narrative
Hu-friedy has requested additional information from the user facility regarding the patient status.However; to date a response has not been received.The periotome subject of the event was returned to hu-friedy for evaluation and the device was confirmed to have fractured near the tip.The evaluation found that the area where the fracture occurred was bent.The observed damage is indicative of excess force being applied to the device over time subsequently resulting in the reported event.The device was manufactured in 2016 making it approximately 6 years old.A follow-up mdr will be submitted should additional information becomes available.

• Brand Name: PERIOTOME
• Common Device Name: PERIOTOME
• 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 ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14239390
• Report Number: 1416605-2022-00002
• Device Sequence Number: 11931388
• Product Code: EMJ
• UDI-Device Identifier: 10889950020453
• UDI-Public: 10889950020453
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: PT1X
• Device Catalogue Number: PT1X
• Device Lot Number: 0216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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