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

Model Number	459151
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.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
Result of investigation: during the technical investigation of the returned product, the following was found: pull rod broken.The diagnosed issue is not caused by a production defect.The most probable root cause of the breakage of the pull rod is excessive force.There are signs of wear/scratches on the surface of the fixed jaws, which means that it cannot be ruled out that material other than that intended was attempted to be cut.In addition, corrosion can be seen on the lock on the back, which can also have a negative effect on the material properties of the pull rod.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SILCUT STAMMBERGER PUNCH,RIGHT SIDE DOWN
• Common Device Name: SILCUT STAMMBERGER PUNCH,RIGHT 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: 22099036
• Report Number: 9610617-2025-00909
• Device Sequence Number: 7390179
• Product Code: LRC
• UDI-Device Identifier: 04048551164808
• UDI-Public: 04048551164808
• 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): 10/09/2025

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: 459151
• Device Catalogue Number: 459151
• Device Lot Number: RM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• 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: 10/07/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 10/09/2025
• 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