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

Catalog Number 1460000000

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

This report summarizes 11 malfunction events, where it was reported the devices experienced reduced brake force.There was no patient involvement.

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.4 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.7 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Manufacturer Narrative

6 pending devices were not evaluated, but reviewed by data and found that there was no defect with the devices.Section h codes have been updated.1 device is still pending evaluation.

Event Description

This report summarizes 11 malfunction events, where it was reported the devices experienced reduced brake force.There was no patient involvement.

Event Description

This report summarizes (b)(4) malfunction events, where it was reported the devices experienced reduced brake force.There was no patient involvement.

Manufacturer Narrative

The device pending evaluation was evaluated in the field and the issue was not able to be confirmed.Section h codes have been updated to reflect this.

• Brand Name: PRIME TC SWING-AWAY MODEL
• Type of Device: 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17997250
• MDR Text Key: 326605161
• Report Number: 0001831750-2023-01164
• Device Sequence Number: 1
• Product Code: INN
• UDI-Device Identifier: 07613327282665
• UDI-Public: 07613327282665
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 11
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1460000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1