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

Model Number	SU16005
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	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the tip of their vital crile needle wood holder detached.The procedure was completed successfully using a different device.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event is being returned to steris for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris for evaluation.Upon evaluation, it was discovered that the distal end of the needle holder was broken, however a cause of the reported event could not be determined.The vital crile-wood 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.Avoid mechanical shock or overstressing the devices.Close distal ends prior to insertion or removal through cannulas." a steris account manager provided in-service training on the proper use and operation of the vital crile-wood needle holder.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): STERIS DEUTSCHLAND GMBH; kantstrasse 33/1; wurmlingen, baden-wurttemberg, D-785 73; GM D-78573
• Manufacturer (Section G): STERIS DEUTSCHLAND GMBH; kantstrasse 33/1; wurmlingen, baden-wurttemberg, D-785 73; GM D-78573
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24095273
• Report Number: 3006554912-2026-00001
• Device Sequence Number: 21386105
• Product Code: MDM
• UDI-Device Identifier: 10885403061912
• UDI-Public: (01)10885403061912(10)XHCV11
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 01/16/2026

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: SU16005
• Device Catalogue Number: SU16005
• Device Lot Number: (10)XHCV11
• 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: 11/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown