MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME TC SWING-AWAY MODEL; CHAIR, ADJUSTABLE, MECHANICAL

Catalog Number	1460000000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between october 1-december 31, 2025.This report summarizes 17 malfunction event(s), where it was reported the device experienced brakes cannot be engaged; false engagement of brakes.No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.7 device(s) was/were functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.Evaluation results findings (components/results).1 device: wheel / wear problem.2 devices: part/component/sub-assembly term not applicable / mechanical problem identified.1 device: fastener / device migration.1 device: rod/shaft / device migration.1 device: gears / mechanical problem identified.1 device: actuator / mechanical problem identified.4 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.Evaluation results findings (components/results).4 devices: appropriate term/code not available / no findings available 6 devices are pending evaluation.Evaluation results (components/results).6 devices: insufficient information / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
The 5 devices that were pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results).2 devices: actuator/mechanical problem identified.3 devices: part/component/sub-assembly term not applicable/mechanical problem identified.1 device that was pending was evaluated and it was determined the device experienced the foot rest won't latch/lock, which is not reportable.
Event or Problem Description
This report now summarizes 16 malfunction event(s), instead of 17.

• Brand Name: PRIME TC SWING-AWAY MODEL
• Common Device Name: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 24183876
• Report Number: 0001831750-2026-99089
• Device Sequence Number: 15947491
• Product Code: INN
• UDI-Device Identifier: 07613327282665
• UDI-Public: 7613327282665
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 16
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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
• Device Catalogue Number: 1460000000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2026
• Supplement Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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
• Patient Sex: Unknown