MAUDE Adverse Event Report: SKYTRON SKYTRON SPLIT LEG SECTION FOR 6700 SERIES & 3600B; SURGICAL TABLE ACCESSORY

Model Number	4-030-61
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	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Skytron authorized representative visited the facility to inspect the device and did not find any evidence that the device was defective or malfunctioning.Based on the information available the probable cause of the incident is that the accessory was not secured to the surgical table properly by the user.
Event or Problem Description
Skytron technical support received a phone call from froedtert memorial lutheran hospital describing an incident involving a skytron split leg section for 6700 series & 3600b table accessory.The facility alleges that they were set up for a case and when the table was adjusted to reverse trendelenburg position the split leg accessory disengaged from the surgical table and the patient slid to foot going into straddle position on the ground.No patient or staff injuries were reported as a result of the incident.

• Brand Name: SKYTRON SPLIT LEG SECTION FOR 6700 SERIES & 3600B
• Common Device Name: SURGICAL TABLE ACCESSORY
• Manufacturer (Section D): SKYTRON; 5085 corporate exchange blvd s; grand rapids MI 49512
• Manufacturer (Section G): CONCEPT METAL MACHINING LLC; 5320 6 mile ct nw; comstock park MI 49321
• Manufacturer Contact: lex hejna ; 5085 corporate exchange blvd se; grand rapids, MI 49512 ; 6165592700
• MDR Report Key: 22056256
• Report Number: 1825014-2025-00002
• Device Sequence Number: 4084005
• Product Code: FQO
• UDI-Device Identifier: 10841736112745
• UDI-Public: 10841736112745
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: 4-030-61
• Device Catalogue Number: 4-030-61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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