MAUDE Adverse Event Report: HOLGER ULLRICH EXTENSION SET; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100366A0

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.

Event Description

The following was reported.An issue related to the extension device caused a break of the femur.Manufacturer reference# (b)(4).

Manufacturer Narrative

A getinge-maquet field service engineer has investigated the affected skid.The result of this investigation was, that the castors were blocked due to oxidation.A review of the complaints database for the affected product and similar products was performed.This review revealed that no other complaints for this kind of malfunction (castors of skid stuck and/or oxidated) was received.We assume inappropriate cleaning to be the most probable root cause for this kind of malfunction.In the instructions for use (ifu) the user is told how to clean and disinfect the product.The user is warned in the ifu concerning the risks related to improper cleaning as follows: "caution! improper cleaning and disinfection can cause property damage! observe the manufacturers' instructions for concentrations of cleaning agents and disinfectants; perform visual and functional inspections after each cleaning and disinfection process." "danger! risk due to mishandling of cleaning agents and disinfectants!; the entire cleaning process may only be completed by qualified technicians.For information on concentration, temperature and contact and drying times, refer to the instructions of the detergent and disinfectant manufacturer.Observe current national and international regulations for hygiene in the medical field.Observe the cleaning and hygiene regulations of the hospital".Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

On the device a skid can slide on a traction bar.The skid is equipped with rollers, so it can slide on the bar and with a brake, so it can be locked on the bar.On this skid the patients foot can be fixed via a screw tension device and a suitable boot.The complete traction bar can be moved.It can be lifted, lowered and moved to each side.When the traction bar is moved and a patients' foot is fixed on the skid, the skid needs to be able to move on the traction bar.In this case the rollers of the skid were blocked and the skid could not move on the traction bar.When the traction bar was moved, this led to a fracture of the patients femur.Manufacturer reference# (b)(4).

• Brand Name: EXTENSION SET
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 11560954
• MDR Text Key: 243365025
• Report Number: 3013876692-2021-00022
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 100366A0
• Device Catalogue Number: 100366A0
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2022
• Distributor Facility Aware Date: 02/17/2022
• Device Age: 68 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 78 KG