MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOSEMANN FRONTAL SINUS; SINUS PUNCH 70 DEGREE UPTURNED

Model Number	651503
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an event with a 651503 hosemann frontal sinus/recess punch.According to the information received from the onsite endoscopic specialist the top piece of the punch broke off during a frontal sinus procedure.The procedure was delayed 15min while obtaining replacement instrument.Patient harm is not known at date of this report.
Additional Manufacturer Narrative
Manufacturing site evauation:the top portion of the 70 degree punch was broken off per onsite endoscopic specialist during procedure.The broken piece was not returned.The patient underwent x-rays for verification that no piece was left behind.No patient harm was noted.Investigation is on-going.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).
Additional Manufacturer Narrative
Per manufacture findings: at the distal end, the jaw (single component) which is welded circumferentially on the guide rod has come loose (was not sent along) on the surface of the guide rod you can see rough grinding marks and a rounded shape compared to a new item from the production (slightly pointed and finely ground surface).In addition, there are places where welding was attempted.It can be assumed that this article was subsequently machined, for example, material was removed from the weld seam when the surface was ground over, weakening it and causing it to break.Based on the fault patterns described, a third-party repair is to be assumed.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: HOSEMANN FRONTAL SINUS
• Common Device Name: SINUS PUNCH 70 DEGREE UPTURNED
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17479347
• Report Number: 9610617-2023-00202
• Device Sequence Number: 2647626
• Product Code: LRC
• UDI-Device Identifier: 04048551188606
• UDI-Public: 4048551188606
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 651503
• Device Catalogue Number: 651503
• Device Lot Number: MN07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic