MAUDE Adverse Event Report: MAQUET GMBH ARTHREX TRIMANO FORTIS; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100230R0

Device Problems Positioning Failure (1158); Unstable (1667)

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

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On 6th october, 2022 getinge became aware of an issue with 100230r0 arthrex trimano fortis.As it was stated, during preparation for shoulder arthroscopy procedure, the release handle of arthrex trimano fortis stopped working and the device lost all stability following its attachment to the table.The patient was already anesthetized, positioned and draped on the table.The surgeon ended up using a padded mayo stand and required help of the his assistant for the entire procedure.The procedure was completed successfully with a delay of around 20 minutes.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with 100230r0 arthrex trimano fortis.During preparation of the patient for shoulder arthroscopy procedure, the release handle of arthrex trimano fortis stopped working and the device lost all stability following its attachment to the table.The patient was already anesthetized, positioned and draped on the table.The surgeon ended up using a padded mayo stand and required help of the assistant for the entire procedure.The procedure was completed successfully with a delay of around 20 minutes.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.The affected getinge device was returned to the factory for further investigation performed by the process assurance department.Visual and functional inspection of the device revealed that there were several impact marks, signs of the strong collision and the locking washer on the threaded spindle of the three-star handle has shifted, thus the three-star handle can be screwed out of the lifting body finished part.During the testing of the unlock function, release mechanism cannot be actuated, all joints were unlocked and joint 1 cannot be moved.Test of the lock function revealed that the joints cannot be locked and all joints, except joint 1, slip through.The arthrex trimano fortis had a strong collision marks and impact points at various joints, which indicate overloading - incorrect operation.In the user manual the user is informed to avoid collision, properly clean the device and to perform a visual inspection before each use.Based on the evaluation performed in the factory the root cause for the reported issue is user error.With the investigation performed it was concluded that upon the event occurrence, the device was being used for patient¿s treatment, thus was also directly involved with the reported incident.Several malfunctions were found in the device so it was considered that getinge device was not up to the specification.There was one similar complaint related to this issue investigated herein, therefore, the failure ratio is (b)(4).%.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The correction of h4 device manufacture date and h6 component codes fields deems required.This is based on the internal evaluation and additional information that has been received.Previous h4 device manufacture date: 03/06/2018.Corrected h4 device manufacture date: 03/12/2018.Previous h6 component codes: safety|locking mechanism||3083.Mechanical|holder||838.Corrected h6 component codes: mechanical|holder||838.

• Brand Name: ARTHREX TRIMANO FORTIS
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; avenue de la pomme de pin; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; avenue de la pomme de pin; rastatt ; GM
• MDR Report Key: 15678980
• MDR Text Key: 307034633
• Report Number: 8010652-2022-00036
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100230R0
• Device Catalogue Number: 100230R0
• Device Lot Number: 10198471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1