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

Model Number 651503

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2023

Event Type  malfunction  

Event 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.

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).

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
• Type of Device: 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
• MDR Text Key: 320588010
• Report Number: 9610617-2023-00202
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 04048551188606
• UDI-Public: 4048551188606
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic