MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SILCUT STAMMBERGER PUNCH, LEFT SIDE DOWN

Model Number	459152
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 down biters were found broken after minimal use, despite not being used on excessively hard bone.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: during technical inspection of the returned device, the following was found: significant deformation can be seen on the cutting edge, which has a negative effect on the cutting quality and the cut pattern.This deformation can occur, for example, when attempting to cut material that is not intended for use.On the other hand, it can be seen that the inner pull rod runs somewhat more heavily.The ri provides information on how to maintain/oil the instrument.This event is filed under internal complaint id (b)(4).

• Brand Name: SILCUT STAMMBERGER PUNCH, LEFT SIDE DOWN
• Common Device Name: SILCUT STAMMBERGER PUNCH, LEFT SIDE DOWN
• 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: 22087089
• Report Number: 9610617-2025-00922
• Device Sequence Number: 20564369
• Product Code: LRC
• UDI-Device Identifier: 04048551164815
• UDI-Public: 04048551164815
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 459152
• Device Catalogue Number: 459152
• Device Lot Number: YM01
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown