MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 100 THIN SWIVEL DIRECT FLOW, 30K

Model Number	UI30SD100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the reported event was returned to hu-friedy for evaluation.The evaluation suggested that the breakage was likely due to wear associated with extended use over time.The insert, was over 17 years old.No further actions were deemed necessary as the insert was far beyond its typical usage span.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
The user facility reported that during a dental procedure the tip of ultrasonic insert broke in patient's mouth.The patient swallowed the tip and was sent to the er for evaluation.The hospital released the patient and the broken end of the material that was swallowed did pass through bowel movements.No medical surgery or other interventions were required.

• Brand Name: 100 THIN SWIVEL DIRECT FLOW, 30K
• Common Device Name: 100 THIN SWIVEL DIRECT FLOW, 30K
• 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 street; chicago, IL
• MDR Report Key: 20914286
• Report Number: 1416605-2024-00014
• Device Sequence Number: 7825573
• Product Code: ELC
• UDI-Device Identifier: 10889950075620
• UDI-Public: (01)10889950075620
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K012060
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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: UI30SD100
• Device Catalogue Number: UI30SD100
• Device Lot Number: V7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2007
• 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: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White