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

Model Number	72203299
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354); Overheating of Device (1437); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).
Event or Problem Description
It was reported that during set up, the spider 2 tenet was dropped so the body is cracked and it was leaking oil.The device also started to overheat and a burning smell was coming from the inside and it would not hold position.A back up device was available to complete the procedure.There was no delay and no further complications were reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection was performed.The enclosures were damaged and taped together.The battery, charger and foot switch were also returned.No visible excess or pooling oil was noted on the outside of the device.A functional evaluation was performed.A known good test battery was utilized.The device would not power up to pressurize.The fuse on the control board checked as good.No burned components were noted on the control board.The pre-pressure test jig was utilized to bypass the control board.The device would still not power up to pressurize.Further investigation revealed that the brushes within the device's motor were burned.The motor was defective.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 has been associated with a component failure.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, wear from prolonged use, a seal failure that can result in the loss of oil and prevent the device from properly pressurizing and maintaining position.No containment or corrective actions are recommended at this time.

• Brand Name: 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: 16440962
• Report Number: 1643264-2023-00093
• Device Sequence Number: 3198566
• Product Code: GDC
• UDI-Device Identifier: 00885554023534
• UDI-Public: 00885554023534
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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: 72203299
• Device Catalogue Number: 72203299
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 02/25/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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