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

Model Number PT1X

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 299362951
• Report Number: 1416605-2022-00002
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 10889950020453
• UDI-Public: 10889950020453
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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