MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HDS, PATIENT PLATFORM; APPARATUS, TRACTION, NON-POWERED

Model Number	AR-6529-01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hip distractor system is designed to position, support and/or distract the patient¿s hip, posterior lower torso and foot for hip surgery.These devices are intended to be used by healthcare professionals within the operating room setting.The baxter technician found excessive damage showing signs of either being dropped or misused.It was noted that many components either broken bent or gouged.Baxter technical service provided the account the estimates on repairs, however the account has declined repair.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the reported event 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 hds patient platform had hds patient platform had a piece from the central area where the support slides detach.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: HDS, PATIENT PLATFORM
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM MEXICO; ave.del telefono; no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24664437
• Report Number: 3006697241-2026-00110
• Device Sequence Number: 9344644
• Product Code: HST
• UDI-Device Identifier: 00615521004712
• UDI-Public: (01)00615521004712(11)241125
• 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): 03/23/2026

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-6529-01
• Device Catalogue Number: AR-6529-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/23/2026
• 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