MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; NEEDLE HOLDER

Model Number	SU16062
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported while using their dorsey fenestrated grasper during patient procedures that a screw fell into the surgical field.No report of injury or procedure delaythe user facility reported that three of their mayo hegar needle holders have caused suture needles to break.The procedures were completed successfully.No report of injury.
Event or Problem Description
The user facility reported that three of their mayo hegar needle holders have caused suture needles to break.The procedures were completed successfully.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned to the supplier for evaluation.The device was tested and found to be operating according to specification.No issues with the function of the device were noted.The mayo hegar needle holder ifu states, "use of a device for a task other than what it is intended for will usually result in a damaged or broken device.Prior to use, inspect devices to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage.Avoid mechanical shock or overstressing the devices.Close distal ends prior to insertion or removal through cannulas." steris offered in-service training on the proper use and operation of the mayo hegar needle holder; however, the user facility declined.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22612575
• Report Number: 1527821-2025-00013
• Device Sequence Number: 15540025
• Product Code: MDM
• UDI-Device Identifier: 10885403002465
• UDI-Public: (01)10885403002465(10)A25XHC
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: SU16062
• Device Catalogue Number: SU16062
• Device Lot Number: (10)A25XHC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown