MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; CURETTE

Model Number	AU5600
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via user facility medwatch report number (b)(4) that during an operative procedure, the curette broke during use.No report of injury.
Additional Manufacturer Narrative
The complaint information was sent to the supplier for evaluation.An investigation is currently in process.A follow-up mdr will be submitted once additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was discarded and not available for evaluation.Without the device, a root cause of the reported event could not be determined.The operator manual for the curette states, "prior to use, inspect devices to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage.Avoid mechanical shock or overstressing the devices.Close distal ends prior to insertion or removal through cannulas.Always use caution when inserting or removing devices through the cannula.Lateral pressure on the device during removal can damage the working tip, and/or shaft of the device.Be sure the tips are closed and the device is pulled straight out until completely clear of the cannula to avoid catching the valve assemblies in cannulas or dislodging the cannula." no additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: CURETTE
• Manufacturer (Section D): STERIS CORPORATION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19381354
• Report Number: 1423507-2024-01017
• Device Sequence Number: 14384590
• Product Code: JYG
• UDI-Device Identifier: 10885403008412
• UDI-Public: (01)10885403008412(10)C21XSF
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AU5600
• Device Catalogue Number: AU5600
• Device Lot Number: (10)C21XSF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 05/28/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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