MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PROBE, 4 MM, 12 CM; ENDOSCOPIC SURGICAL PROBE

Model Number	28145W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine l knee arthroscopy the knee structures were probed, with the device.Upon checking the acl the hook broke.The end was unretrievable.Arthrotomy was performed to no avail.The patient will be checked in the ongoing week.Metal still in knee.The initial surgery was aborted and had to switched to an open procedure (arthrotomy of knee).The broken off part could not be recovered.Additional x-rays were taken.As the end of the hook is embedded in the knee an initial aborted procedure, a switch to an open procedure, additional x-rays and a planned additional surgery, the event is deemed reportable.
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).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation on february 20,2025.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the most probable root cause is mechanical damage caused by the user.Since force is exerted on the tip of the hook (e.G., through leverage), this can lead to breakage.In addition, the product was manufactured in 2018, so it can be assumed that it has been used frequently and overhauled.This can also have a negative effect on the material properties.Due to corrosion on the surface, errors during reconditioning cannot be ruled out (this can also have a negative effect on the material properties).The corresponding ifu 28145w_en_v47.1_03-2023_ri_ce describes in chapter 8 "visual inspection" to check products for the following points: visible soiling, damage and corrosion, completeness and dryness and to discard damaged and corroded medical devices.In chapter 9.1 "functional check" the following tests must be carried out to detect functional limitations: check the surface of the product for mechanical integrity and changes, check the labeling for legibility and check the product for mechanical integrity.The conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.According to the information provided the broken off part "hook tip" (approximately 5 x 4 mm in size) remained in the body.If the part remains for a short time - there is no acute risk of a toxic or immunological reaction.Nevertheless, the foreign body should be identified as quickly as possible and removed if necessary, as it is expressly not an implantable material.Since there is a possibility of unretrieved device fragment embedding on the metaphysis of the femur, over a long time, this risk has to be analysed appropriately.Such unretrieved device fragment could potentially be mutagenic and or carcinogenic specially taken the high cell turn over in the metaphysis in to account.Higher precision imaging such as ct or mrt can be recommended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: PROBE, 4 MM, 12 CM
• Common Device Name: ENDOSCOPIC SURGICAL PROBE
• 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: 21425189
• Report Number: 9610617-2025-00263
• Device Sequence Number: 7792743
• Product Code: LXH
• UDI-Device Identifier: 04048551095607
• UDI-Public: 04048551095607
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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: 28145W
• Device Catalogue Number: 28145W
• Device Lot Number: TR04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 02/20/2025; 07/28/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 02/25/2025; 07/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown