MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SHOULDER SUSPENSION TOWER; PROTECTOR, SKIN PRESSURE

Model Number	AR-1650-01
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that shoulder suspension tower fell to the floor and knocked a piece of axis, making it impossible to glide, suspend or lock.The device was located at the account and occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The shoulder suspension tower is designed to position, support and/or distract the patient¿s shoulder in a variety of surgical procedures including, but not limited to lateral arthroscopic and mini-open shoulder surgery.These devices are intended to be used by healthcare professionals within the operating room setting.During on-site inspection, baxter technician found the trigger spring broken, the stop pin missing and the pulley clutch stuck.Technician replaced the damaged parts.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of shoulder suspension tower collapsing were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.

• Brand Name: SHOULDER SUSPENSION TOWER
• Common Device Name: PROTECTOR, SKIN PRESSURE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; 100 discovery way; acton MA 01720
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22816679
• Report Number: 3010216206-2025-00021
• Device Sequence Number: 8666709
• Product Code: FMP
• UDI-Device Identifier: 00615521004521
• UDI-Public: (01)00615521004521(11)250314
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: Other
• Device Model Number: AR-1650-01
• Device Catalogue Number: AR-1650-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown