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.

• 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
• MDR Report Key: 21647619
• Report Number: 2020550-2025-00465
• Device Sequence Number: 15381898
• Product Code: LRC
• UDI-Device Identifier: 04048551253229
• UDI-Public: 04048551253229
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2025
• Report Date (Section F): 03/19/2025

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown