MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL, SPIDER 2, TENET 7615; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	72203299S
Medical Device Problem Codes	Overheating of Device (1437); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the spider 2 tenet was stuck, was getting hot, and was smelling like burn.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed that there was no physical damage on the exterior of the product and no accessories were included.A functional evaluation was performed on the returned device and found that the device motor runs continuously.It was also noted during testing, that arms of the device were stiff and difficult to move.No overheating or burning smell noted.Upon opening device no damage to the pcb board was found.The piston migration was at 3.0 inches.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause of the device getting hot and the burning smell could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include the battery or motor becoming warm through normal operation.The root cause of the stuck device has been associated with a component failure.Factors that could have contributed to the failure include debris ingression or prolonged pressurization, causing damage to the seals, spacers, pressure rings, or pressure cups within the joints of the device.No containment or corrective actions are recommended at this time.

• Brand Name: SVCE REPL, SPIDER 2, TENET 7615
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18571282
• Report Number: 1643264-2024-00051
• Device Sequence Number: 7077334
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: 885554029673
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72203299S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown