MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CURETTE, SMALL

Model Number	224002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "medical device used to perform atticotomy during stapedotomy surgery.During the procedure, one end broke off and hit the ossicular chain without caus-ing permanent damage to the patient.It was necessary to search for the iron fragment inside the aspirator, as there was the possibility that it could have stuck in the middle ear.The fragment was found in the aspiration system (receptal)".No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device was returned to the manufacturing site for evaluation as documented in section d9.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Device evaluation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, "end of instrument broke off in patient", could be confirmed.A curette is used to scrape/remove biological material, which means that forces can act on the "spoon" of the curette from any direction.These forces can lead to deformation.Due to the age (manufactured in may 2015) of the curette (number of assumed preparations and applications), the presumed cause is the negative effects on the material properties, which also led to breakage (end of service life).This event is filed under internal complaint id (b)(4).

• Brand Name: CURETTE, SMALL
• Common Device Name: CURETTE, SMALL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23019479
• Report Number: 9610617-2025-01577
• Device Sequence Number: 18577280
• Product Code: LRC
• UDI-Device Identifier: 04048551078310
• UDI-Public: 04048551078310
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2025

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: 224002
• Device Catalogue Number: 224002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 12/11/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/11/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown