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

Catalog Number	72203299
Medical Device Problem Codes	Overheating of Device (1437); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the tenet 2 spider battery was overheating and was not locked.The procedure was completed using the same reported device with a new charged battery.There was a delay of less than 30 minutes.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found the device returned without obvious deformity but scuffs and scratches to the case.There is free oil in the case and it smells of burning oil.No accessories were returned with the device.A functional assessment of the device found that the device pressurizes and releases randomly when tested with a reference battery and when tested with a reference footswitch and drapeswitch the device functioned as designed with the drapeswitch and footswitch.The battery began to heat appreciably when the device was used for 15 minutes.The piston migration is 2.63".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 which could have contributed to the device positioning problem event include a seal failure that can result in the loss of oil and prevent the device from properly pressurizing and maintaining position.Factors that may have contributed to the overheating event include the device taking longer than normal to pressurize because of the depletion of oil.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: 19009376
• Report Number: 1643264-2024-00212
• Device Sequence Number: 9383556
• Product Code: GDC
• UDI-Device Identifier: 00885554023534
• UDI-Public: 00885554023534
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: 72203299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 03/31/2024
• Supplement Report FDA Received Date: 05/07/2024
• 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