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

Model Number	72203299S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spider positioner was overheating when it was used.No case reported; therefore, there was no patient involved.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection found the device was received pressurized.No accessories included.A functional evaluation was performed using a test battery.The device was depressurized.The dumbbell joint was stiff.The rocker switch was activated and the device took approximately five seconds to pressurize.The set up button was utilized and multiple movements were performed.Each time the device was delayed in pressurizing.There were two attempts where the motor continuously ran and the battery began to grow warm.No components were hot to the touch.Piston migration was 2.61 inches.The root cause reported for overheating and the delayed pressurization found during the device evaluation were associated with a component failure.Factors which could have contributed to the reported event include a seal failure can result in air getting into the hydraulic system and can cause the device to take an extended period to pressurize which can cause the battery to get warm.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.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: 16954934
• Report Number: 1643264-2023-00182
• Device Sequence Number: 7012668
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: 00885554029673
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023

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 Model Number: 72203299S
• Device Catalogue Number: 72203299S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 12/26/2023
• 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