MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HDS LONG OPERATIVE LEG SPAR; APPARATUS, TRACTION, NON-POWERED

Model Number	AR-6529-16
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that stabilizer leg hds had stabilizer leg missing screws and caused device to fall out.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
The investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
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.Upon inspection, baxter field service technician determined that the standoff had three screws missing.A replacement standoff with screws were replaced by the baxter technician.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 device fall due to missing screws were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.

• Brand Name: HDS LONG OPERATIVE LEG SPAR
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• 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: 23763743
• Report Number: 3010216206-2025-00033
• Device Sequence Number: 21355027
• Product Code: HST
• UDI-Device Identifier: 00615521004736
• UDI-Public: (01)00615521004736
• 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,Followup
• Report Date (Section B): 02/26/2026

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: Other
• Device Model Number: AR-6529-16
• Device Catalogue Number: AR-6529-16
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/26/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown