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 january 1- march 31, 2026.This report summarizes 12 malfunction events(s), where it was reported the devices 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.8 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.Evaluation results findings (components/results) 1 device: actuator / mechanical problem identified 3 devices: part/component/sub-assembly term not applicable / mechanical problem identified 2 devices: actuator; gears / mechanical problem identified 1 device: chassis/frame / deformation problem 1 device: foot pedal / deformation problem 1 device was not evaluated, as a probable cause for the issue was identified during communication between the customer and stryker and no further assistance was requested by the customer.Evaluation results findings (components/results) 1 device: actuator / mechanical problem identified 3 devices are pending evaluation.Evaluation results findings (components/results) 3 devices: insufficient information / results pending completion of investigation there was no remedial action taken.This device is not labeled for single use.

• 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: 24966321
• Report Number: 0001831750-2026-99220
• Device Sequence Number: 17391314
• 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: 12
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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
• Device Catalogue Number: 1460000000
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/23/2026
• 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