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

Catalog Number	72203299
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair, a spider 2 tenet made three different and fully charged batteries extremely hot and was unlocking constantly, causing it to be unusable.There were no necessity of additional interventions as a result of the reported issue.Surgery resumed after a non-significant delay with a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.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.A visual inspection did not reveal any issue.A functional evaluation found delayed pressurization but the device was able to lock in place.15 movements were performed and delayed pressurization was observed each time but the battery did not get hot.The positioner failed the 30lb weight test at the hinge joint.Piston migration indicated significant oil loss.Piston migration was 2.7 inches.The root cause for the reported deficiency of positioning problem was determined to be a component failure.Factors which could have contributed to the reported event include a seal failure that can result in the loss of oil and prevent the device from properly pressurizing and maintaining position, also degradation of the seals can occur from extended use or storing the device in a pressurized state.The root cause for the reported overheating could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the reported event include a continuously running motor can lead to increased current draw from the battery leading to increased temperature.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: 17607822
• Report Number: 1643264-2023-00480
• Device Sequence Number: 17682741
• Product Code: GDC
• UDI-Device Identifier: 00885554023534
• UDI-Public: 00885554023534
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/05/2024

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: 08/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown