MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SINUS BURR 35K, STERILE, 5X

Model Number	41335DW
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that shaver burr didn't fit well into shaver handpieces.Drillcut handpiece stopped working during surgical procedure.Surgical procedure (draf type iii frontal sinus) had to be completed without burr by using punches which delayed the procedure.Burr had to be inserted with force.Procedure had to be completed without burr.This caused a surgical delay of 112 minutes.Three other planned procedures within the next 4 weeks had to be cancelled/rescheduled due to unavailability of 40° shaver burrs that fit into handpiece and broken handpiece.Since the procedure had to be rescheduled, this case is reportable.

• Brand Name: SINUS BURR 35K, STERILE, 5X
• Common Device Name: SINUS BURR 35K, STERILE, 5X
• 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
• MDR Report Key: 23729575
• Report Number: 9610617-2025-02448
• Device Sequence Number: 10631910
• Product Code: EQJ
• UDI-Device Identifier: 04048551409909
• UDI-Public: 04048551409909
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 41335DW
• Device Catalogue Number: 41335DW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown