MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PROBE, 4 MM, 8.5 CM

Model Number	28145V
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During palpation of the femoral condyle with the probe hook from arthroscopy kit no.8, the tip broke off inside the joint.Use of an image intensifier in the operating room to locate the metallic fragment inside the joint.We were unable to retrieve the broken piece because it became lodged in an area that is difficult to access, with a risk of nerve injury and bleeding.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Investigation: the device in question (28145v, probe, 4 mm, 8.5 cm, lot number unknown) was not received for investigation.The claimed product was not returned to karl storz tuttlingen.Therefore, physical technical inspection is not possible.Without a return, it is not possible to classify the complaint in detail.Based on the customer's description, the most probable root cause is damage to or breakage of the hook tip due to mechanical overload.Given that the age of the hook is unknown and the component may have undergone numerous reprocessing cycles, the material properties may have been adversely affected.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: PROBE, 4 MM, 8.5 CM
• Common Device Name: PROBE, 4 MM, 8.5 CM
• 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: 23821209
• Report Number: 9610617-2025-02341
• Device Sequence Number: 9486169
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/28/2026

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: 28145V
• Device Catalogue Number: 28145V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 05/28/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown