MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MACRO NEEDLE HOLDER, 5 MM, 33 CM

Model Number	26173KPL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported during a medical procedure on (b)(6) 2024, pin fell out of the distal end of the instrument.They are not sure if the pin fell out before the instrument was brought into the surgery or if it fell out during the case.However, no injuries were reported and no surgical delays.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: no article was sent for investigation, so the complaint cannot be confirmed.A possible cause could be, for example, that a needle or object that was too large was grasped, causing too much pressure on the connection and leading to breakage.Age can also play a role (number of reprocessings /applications assumed), but this is not known.The 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 pickup in similar complaints, no trend was identified.This event is filed under internal complaint id (b)(4).

• Brand Name: MACRO NEEDLE HOLDER, 5 MM, 33 CM
• Common Device Name: MACRO NEEDLE HOLDER, 5 MM, 33 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 20518946
• Report Number: 9610617-2024-00405
• Device Sequence Number: 15394866
• Product Code: GCJ
• UDI-Device Identifier: 04048551098233
• UDI-Public: 04048551098233
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 26173KPL
• Device Catalogue Number: 26173KPL
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 31 YR
• Patient Sex: Female
• Patient Weight: 62 KG