MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ARM SLEEVE CONNECTOR, S3; PROTECTOR, SKIN PRESSURE

Model Number	AR-1650-02
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
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.The shoulder tower was received by baxter.Upon inspection, it was determined that the cable was broken and it was found several cosmetic blemishes.Baxter submitted an estimate for the repair to insurance on behalf of the patient.Customer declined the repair and requested the device to be scrapped.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 a broken connection between upper extremity distraction were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that the should suspension tower and the shoulder suspension pully system became apart.It was discovered during a case.No harm or significant impact to the surgical procedure was reported.

• Brand Name: ARM SLEEVE CONNECTOR, S3
• 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: 22480583
• Report Number: 3010216206-2025-00015
• Device Sequence Number: 8498938
• Product Code: FMP
• UDI-Device Identifier: 00888867245051
• UDI-Public: (01)00888867245051
• 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): 07/11/2025

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: AR-1650-02
• Device Catalogue Number: AR-1650-02
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/11/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown