MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OSTEOTOME, 2 MM, 19 CM

Model Number	484242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported that a fractured end of osteotome with fragment of metal (< 2 mm) left in patient's nasal bone.X-ray was required.Procedure completed successfully with prolongation of 15-60 minutes.Reported patient outcome: fine.It is still under clarification if the metal fragment was retrieved / will be retrieved and how long was the exact prolongation time.
Additional Manufacturer Narrative
As the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.The conducted investigations did not reveal a root cause related to the labelling.The labelling was found to contain adequate instructions and warnings.According to the customer's description, part of the cutting edge/tip is broken off.However, this cannot be confirmed as no item was sent in for inspection.There is also no lot number available, so no statement can be made about the age of the item.One possible cause is that the item is old and the number of times it has been reprocessed/used may have had a negative effect on the material properties and caused them to change.The complaint history did not reveal any pick up in similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: OSTEOTOME, 2 MM, 19 CM
• Common Device Name: OSTEOTOME, 2 MM, 19 CM
• 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: 21647517
• Report Number: 9610617-2025-00465
• Device Sequence Number: 12687867
• Product Code: LRC
• UDI-Device Identifier: 04048551253229
• UDI-Public: 04048551253229
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 07/10/2025

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: 484242
• Device Catalogue Number: 484242
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown