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

Model Number	40712050
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, the device was stuck.The procedure was finished with a backup device.The problem occurred at the beginning of the procedure.There was no hart or smoke development of the device.No death or (unanticipated) serious deterioration 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).
Additional Manufacturer Narrative
Device evaluation: during the manufacturer's technical inspection, the customer's reported issue, "sometimes getting stuck during use," could not be reproduced.After comprehensive testing, no defect was identified in the product.This event is filed under internal complaint id (b)(4).

• Brand Name: DRILLCUT-X II SHAVER HANDPIECE
• Common Device Name: DRILLCUT-X II 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: 22701285
• Report Number: 9610617-2025-01317
• Device Sequence Number: 8945108
• Product Code: ERL
• UDI-Device Identifier: 04048551253632
• UDI-Public: 04048551253632
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K150969
• 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
• Report Date (Section B): 11/26/2025

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: 40712050
• Device Catalogue Number: 40712050
• Device Lot Number: NL8027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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