MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DRILLCUT-X II-35 SHAVER HANDPIECE

Model Number	40712035
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported: when connected to the um600 and operated at a rotation speed of 1,500 rpm (with the blade attached), we observed that the motor occasionally failed to rotate or stopped unexpectedly.At those times, the event log recorded 'id 116: motor is blocked.A similar phenomenon was also observed when the rotation speed was set to 10,000 rpm.However, this issue was not observed when testing with other handpieces.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: DRILLCUT-X II-35 SHAVER HANDPIECE
• Common Device Name: DRILLCUT-X II-35 SHAVER HANDPIECE
• 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: 23544054
• Report Number: 9610617-2025-02075
• Device Sequence Number: 9609463
• Product Code: ERL
• UDI-Device Identifier: 04048551409954
• UDI-Public: 04048551409954
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200318
• 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
• Report Date (Section B): 11/13/2025

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: 40712035
• Device Catalogue Number: 40712035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/13/2025
• 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
• Patient Sex: Unknown