MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY TRACTION BOOT ASSEMBLY TO ORTHOPEDIC SURGICAL TABLE

Model Number	BF538
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a procedure a patient's foot fell out of the traction boot assembly to their orthopedic surgical table.The patient's foot needed to be realigned in the boot assembly causing a procedure delay.No report of injury and the procedure was completed successfully.
Additional Manufacturer Narrative
A steris surgical project manager arrived onsite to inspect the traction boot assembly to their orthopedic surgical table and was unable to duplicate the reported event.The surgical table and traction boot assembly were found to be operating according to specification and returned to service.No repairs were required.The operator manual (150832-354) states in sec.3.4 "using carbon fiber traction unit and accessories; step 3.A.Apply traction boot assembly (see figure 3-4) to patient's anatomy and secure with hook and loop fastener system attached to foot support." a steris account manager offered in-service training on the proper use and operation of their traction boot assembly.The user facility accepted, however, the date of in service training has yet to be scheduled.No additional issues have been reported.

• Brand Name: TRACTION BOOT ASSEMBLY TO ORTHOPEDIC SURGICAL TABLE
• Common Device Name: TRACTION BOOT ASSEMBLY TO ORTHOPEDIC SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15949887
• Report Number: 1043572-2022-00086
• Device Sequence Number: 6604941
• Product Code: HST
• UDI-Device Identifier: 00724995165376
• UDI-Public: 00724995165376
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 12/09/2022

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: BF538
• Device Catalogue Number: BF538
• 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: 11/11/2022
• Initial Report FDA Received Date: 12/09/2022
• 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