MAUDE Adverse Event Report: HU-FRIEDY MANUFACTURING CO., LLC INFINITY 8 INST DD CASSETTE, LAVENDER; INSTRUMENT CASSETTE

Model Number	IMN9086
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
With no cassette in hand, root cause analysis of the issue is limited.Based on a review of return, complaint, and inspection data of all cassettes manufactured with the same base and lid, no abnormalities were noted.The evaluation will be updated when/if the cassette is received.The reprocessing of hu-friedy dental hand instruments and accessories states "inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not use damaged instruments.
Event or Problem Description
Hygienist was punctured by this cassette that had an unfinished edge on the tab.The hygienist was not severely injured.No medical intervention required.

• Brand Name: INFINITY 8 INST DD CASSETTE, LAVENDER
• Common Device Name: INSTRUMENT CASSETTE
• Manufacturer (Section D): HU-FRIEDY MANUFACTURING CO., LLC; 3232 n. rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MANUFACTURING CO., LLC; 3232 n. rockwell st; chicago IL 60618
• Manufacturer Contact: stephanie wasielewski ; 3232 n. rockwell st; chicago, IL 60618
• MDR Report Key: 22063575
• Report Number: 1416605-2025-00004
• Device Sequence Number: 9394416
• Product Code: FSM
• UDI-Device Identifier: 10889950039585
• UDI-Public: (01)10889950039585
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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 Model Number: IMN9086
• Device Catalogue Number: IMN9086
• Device Lot Number: N/A
• 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: 04/23/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown