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

Model Number 143302B0

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/31/2021

Event Type  Injury  

Event Description

The following was reported to us.There was a problem related to the operating table yuno 2.In four cases a fracture of the femur occurred following a total hip prosthesis surgery.The event date of three cases are (b)(6) 2021, (b)(6) 2021 and (b)(6) 2021.The event date of the 4th case is unknown.The extension plate 143366ac "carbon-fibre extension plate 3" was used in theses surgeries.Further information concerning how these incidents happened and in which relation they are to the operating table were requested, but not yet provided.Manufacturer reference# (b)(4).

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.The name of the affected clinic is: (b)(6).The initial reporters name is: (b)(6).

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.In four cases a fracture of the femur occurred following a total hip prosthesis surgery.The event dates of three cases are july 31th 2021, november 8th 2021 and november 26th 2021.The event date of the 4th case is unknown.The extension plate 143366ac "carbon-fibre extension plate 3" was used in these surgeries.Complaint ref#: (b)(4).

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.In four cases a fracture of the femur occurred following a total hip prosthesis surgery.We decided to report the issue due to serious injuries.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 was 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.The correction of b5 describe event or problem, d3 manufacturer, h4 manufacture date, h6 medical device - problem code, h8 usage of the device fields deems required.This is based on the additional information that has been received and internal evaluation.Previous b5 describe event or problem: the following was reported to us.There was a problem related to the operating table yuno 2.In four cases a fracture of the femur occurred following a total hip prosthesis surgery.The event date of three cases are july 31th 2021, november 8th 2021 and november 26th 2021.The event date of the 4th case is unknown.The extension plate 143366ac "carbon-fibre extension plate 3" was used in theses surgeries.Further information concerning how these incidents happened and in which relation they are to the operating table were requested, but not yet provided.Manufacturer reference#: (b)(4).Corrected b5 describe event or problem: 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.In four cases a fracture of the femur occurred following a total hip prosthesis surgery.The event dates of three cases are july 31th 2021, november 8th 2021 and november 26th 2021.The event date of the 4th case is unknown.The extension plate 143366ac "carbon-fibre extension plate 3" was used in these surgeries.Previous d3 manufacturer holger ullrich.Corrected d3 manufacturer maquet gmbh.Previous h4 manufacture date 01/15/2021.Corrected h4 manufacture date 01/18/2021.Previous h6 medical device - problem code.Insufficient information ||| 3190.Corrected h6 medical device - problem code.Use of device problem |improper or incorrect procedure or method || 2017.Previous h8 usage of the device unknown.Corrected h8 usage of the device reuse.

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.On (b)(6) 2021, a fracture of the femur occurred following a total hip prosthesis surgery.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.On (b)(6) 2021, a fracture of the femur occurred following a total hip prosthesis surgery.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.The correction of b5 describe event or problem and a1 patient identifier fields deems required.This is based on the internal evaluation.(b)(6).Previous b5 describe event or problem: 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.In four cases a fracture of the femur occurred following a total hip prosthesis surgery.The event dates of three cases are (b)(6) 2021.The event date of the 4th case is unknown.The extension plate 143366ac "carbon-fibre extension plate 3" was used in these surgeries.Corrected b5 describe event or problem: 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.On (b)(6) 2021, a fracture of the femur occurred following a total hip prosthesis surgery.The extension plate 143366ac "carbon-fibre extension plate 3" was used in the surgery.

• Brand Name: YUNO 2 EU WITH AUTODRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: holger ullrich ; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 12967804
• MDR Text Key: 281984752
• Report Number: 3013876692-2021-00060
• 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: Distributor
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2022
• Distributor Facility Aware Date: 09/27/2022
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2022
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 143366AC CARBON-FIBRE EXTENSION PLATE 3.
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose