MAUDE Adverse Event Report: STERIS CORPORATION; LEG POSITIONER

Model Number	LEG POSITIONER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The positioner 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.
Event or Problem Description
The user facility reported that during a patient procedure a piece of the split leg positioner to their surgical table broke.The procedure was completed successfully following a short delay using a different accessory.No report of injury.
Additional Manufacturer Narrative
The leg positioner subject of the reported event was returned to steris for evaluation.Upon evaluation, it was discovered that the joint where the carbon fiber board connects to the metal rail attachment assembly was damaged; however, a cause of the damage could not be determined.The user facility was provided with a new leg positioner.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: LEG POSITIONER
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24200762
• Report Number: 1043572-2026-00013
• Device Sequence Number: 15905081
• Product Code: BWN
• UDI-Device Identifier: 00724995225117
• UDI-Public: (01)00724995225117(11)251205
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: LEG POSITIONER
• Device Catalogue Number: BF351
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2025
• 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