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

Model Number	PT1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Instrument was not returned for review.The device history record (dhr) for the subject lot was reviewed and no abnormalities were noted.The return rate for the instrument is low.
Event or Problem Description
User facility reported that the tip broke in the patient's mouth.The patient went to a surgeon to have the tip located and removed.The surgeon found the tip and removed it from the root.

• Brand Name: HU-FRIEDY
• Common Device Name: PERIOTOME, POSTERIOR
• 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 ; 3232 n rockwell st.; chicago, IL 60618 ; 8472574500
• MDR Report Key: 20206986
• Report Number: 1416605-2024-00009
• Device Sequence Number: 20712308
• Product Code: EMJ
• UDI-Device Identifier: 10889950020446
• UDI-Public: 10889950020446
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: PT1
• Device Catalogue Number: PT1
• Device Lot Number: 0623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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 Sex: Unknown