MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG SHUTTLE 3.6 360; SURGICAL TABLE

Model Number	1489491
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on provided pictures the guiding tube came out of the base.The guiding tube is fixed by adhesive in the base of the shuttle.This adhesive bonding is defect.Further investigation for the root cause is ongoing.The defect shuttle was replaced.
Event or Problem Description
The customer reported, the shuttle was raised (height adjustment up) when the guiding tube (which covers the hydraulic cylinder of the height adjustment) came out of the base.In this condition the shuttle is no longer stable.No patient was involved in the event and no injury was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Event or Problem Description
The customer reported, the shuttle was raised (height adjustment up) when the guiding tube (which covers the hydraulic cylinder of the height adjustment) came out of the base.In this condition the shuttle is no longer stable.No patient was involved in the event and no injury was reported.This report was filed in our complaint handling system as complaint # c-(b)(4).
Additional Manufacturer Narrative
The defect shuttle was replaced at the customer location for further investigation at trumpf medical.It was found that the guiding tube came out of the shuttle base which resulted in a no longer stable device.The guiding tube is fixed by adhesive in the base of the shuttle.This adhesive bonding was defect.A further investigation found that the adhesive bonding was not according to the specification.The glued surface was reduced by 30 % in relation to the specification.The root cause for the reduced adhesive bonding was not confirmed for 100% but may caused by a not correct cleaned surface.Even if the glued surface is reduced by 30% it could not be defined how the tube was pulled out of the shuttle base.In the intended use of the device there is only compressive force (guiding tube pressed into shuttle base).To pull the guided tube out the base a tension force is necessary.The guided tube consists of two parts with a sliding bearing to allow the height adjustment of the shuttle.It could not be retraced how a tension force will occur to pull the lower part of the guided tube out of the base.A correct glued tube will need a tension force of approximately five tons.If the glued surface is reduced by 30% it is expected that approximately three tons are needed to pull the tube out.From the initial report of the customer "the shuttle was raised (height adjustment up) when the guiding tube came out of the base." it is not imaginable that this can lead to a tensile force to pull the tube out of the base.There must have been any other impact/ tensile force which damaged the adhesive bonding.However, it could have not been established during the investigation.No systematic issue was determined during the investigation.The job instruction was reviewed and is adequate, all necessary steps are included to ensure a correct adhesive bonding.The defect shuttle was replaced at the customer location.A checkpoint will be included in the production process that the adhesive bonding was done according the job instruction.The employees which are involved in the manufacturing process were trained again on the job instruction and informed of the failure which occurred.

• Brand Name: SHUTTLE 3.6 360
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 13882054
• Report Number: 3007143268-2022-00006
• Device Sequence Number: 5358503
• Product Code: GDC
• UDI-Device Identifier: 00887761993075
• UDI-Public: 887761993075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1489491
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown