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

Model Number 100230R0

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation was still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.(b)(4).

Event Description

It was reported that the handle of the trimano fortis was sticky.That is why the trimano arm was stuck during a surgery and could not be moved.After depressing the handle for several minutes it started to work again.The surgery proceeded and was completed after a 15 minute delay with the same product.No patient injury was reported.(b)(4).

Manufacturer Narrative

The affected device was returned to the factory and investigated.This investigation revealed that deposits of a dried fluid and detergent were found inside the device.The mechanism inside the device was corroded.This corrosion caused the joints and the release mechanism to malfunction.In the instructions for use (ifu) suitable cleaning and disinfection procedures are described.The user is warned as follows concerning the risks related to improper cleaning: "caution: improper cleaning can cause property damage! cleaning agent may not ingress into joints or cracks.Do not use pressure washers nor submerge the trimano in liquid for cleaning! the trimano may not be soaked.Only wipe off with a damp cloth!" we assume that a use error (wrong cleaning) is the root cause for this issue.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.The event site name is (b)(6).

Event Description

Manufacturer reference # (b)(4).

• Brand Name: ARTHREX TRIMANO FORTIS
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 8650923
• MDR Text Key: 146399108
• Report Number: 8010652-2019-00016
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100230R0
• Device Catalogue Number: 100230R0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other