MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STAMMBERGER RHINOFORCE II ANTRUM PUNCH

Model Number	459010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's evaluation: the forceps was disassembled and the slider inside was found broken at the rivet eye.The broken surface shows a fresh ductile break; a part of the slide is missing.The cutting area shows at least on indication for a cut trial of something solid--the cutting edges are not sharp anymore.The ductile appearance indicates a break by overload.During the operation in which the device failed, or in a previous one, there has been a try to cut something rigid--the cutting edge is blunt on several spots.The breakage was most likely due to mechanical overload by trying to cut hard tissue (bones); it is for cartilage only.
Event or Problem Description
As per report received from the factory in (b)(6) regarding an event in (b)(6): during a paranasal sinuses procedure, the forceps lever got blocked all of a sudden.A small metal particle came loose.It was not possible to open or close the forceps anymore.The particle was retrieved.

• Brand Name: STAMMBERGER RHINOFORCE II ANTRUM PUNCH
• Common Device Name: ANTRUM PUNCH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 10092940
• Report Number: 9610617-2020-00060
• Device Sequence Number: 11598770
• Product Code: LRC
• UDI-Device Identifier: 04048551164532
• UDI-Public: 04048551164532
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 459010
• Device Catalogue Number: 459010
• Device Lot Number: TT07
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/27/2020
• 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: Other