MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MACRO NEEDLE HOLDER, 5 MM, 43 CM

Model Number	26178KAF
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.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 the spring of the device broke during surgery.No injury to patient or third party reported.
Additional Manufacturer Narrative
Presumably, a part that does not fit the needle holder was grasped during use and an attempt was made to hold it, causing the spring to break at the weld seam due to overloading.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MACRO NEEDLE HOLDER, 5 MM, 43 CM
• Common Device Name: MACRO NEEDLE HOLDER
• 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: 18222497
• Report Number: 9610617-2023-00380
• Device Sequence Number: 17570178
• Product Code: GCJ
• UDI-Device Identifier: 04048551101537
• UDI-Public: 4048551101537
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 26178KAF
• Device Catalogue Number: 26178KAF
• Device Lot Number: XP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• 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