MAUDE Adverse Event Report: MAQUET GMBH YUNO 2 EU WITH AUTODRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 143302B0

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

On 30th november, 2021 getinge became aware of an issue with one of our mobile tables yuno 2 (143302b0).The following was reported to us.There was a problem related to the operating table yuno 2.A fracture of the femur occurred following a total hip prosthesis surgery.The date of event is unknown.The extension plate 143366ac "carbon-fibre extension plate 3" was used in the surgery.

Manufacturer Narrative

Getinge became aware of an issue with 143302b0 yuno 2 eu with autodrive.It was stated that there was a problem related to the operating table yuno 2.A fracture of the femur occurred following a total hip prosthesis surgery.The date of event is unknown.The extension plate 143366ac "carbon-fibre extension plate 3" was used in the surgery.Based on information provided by subject matter expert (sme) who was present at the operation, the problem was solved by the changed positioning of the counter traction bar in the "3-hole" cfk plate.It was established that when the event occurred, the 143302b0 yuno 2 eu with autodrive met its specification.The provided information indicates that upon the event occurrence, the device was being used for patient treatment.When the event occurred, the 143302b0 yuno 2 eu with autodrive was directly involved with the reported incident.There were no similar complaints related to this issue.Comparing the number of claimed devices to the number of sold devices worldwide, we established that the failure ratio is very low.Following evaluation by the sme who was present at the operation, the placement of the counter extension plate in the central position, causes the femur to rise or block with the corner of the plate and when the stem is introduced weakens the trochanter minor.This indicates user error related to incorrect placement of the counter extension plate.Therefore, the product in question is not defective.The user was informed about improper use.In the ifu (ifu143302xyen04, page 87) the user is informed how to correctly mount extension plate.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any action at this time.

• Brand Name: YUNO 2 EU WITH AUTODRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 15493692
• MDR Text Key: 300711982
• Report Number: 8010652-2022-00031
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 143302B0
• Device Catalogue Number: 143302B0
• Date Manufacturer Received: 11/30/2021
• Date Device Manufactured: 01/18/2021
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 143366AC CARBON-FIBRE EXTENSION PLATE 3
• Patient Outcome(s): Other