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

Catalog Number	1460000000
Medical Device Problem Code	Mechanical Problem (1384)
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 4 malfunction event(s), where it was reported the device experienced reduced/inadequate brake force.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.2 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: actuator / wear problem.1 device: fastener / mechanical problem identified.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.Evaluation results findings (components/results): 1 device: appropriate term/code not available / no findings available.1 device is pending evaluation.Evaluation results findings (components/results): 1 device: insufficient information / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The device that was 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).1 device: fastener/device migration.

• 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: 24184046
• Report Number: 0001831750-2026-99090
• Device Sequence Number: 15956700
• 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: 4
• 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