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

Model Number	72203299
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a shoulder arthroscopy, the spider 2 tenet arm released and the arm dropped to the floor in a sudden collapse.It was a fully charged battery that was inserted at the time.The procedure was successfully completed with a non-significant surgical delay using a back-up device.No further complications were reported.The patient was not injured.
Additional Manufacturer Narrative
H10: internal complaint reference case-(b)(4).H3, h6: the reported device was received for evaluation.A visual inspection did not identify any issue.Functional evaluation found delayed pressurization.The piston migration was 1.9 inches, indicative of oil loss.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 fluid or debris ingress in the joints or storing the device in a pressurized state, both of which can degrade the performance of the joints over time.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: 17250492
• Report Number: 1643264-2023-00333
• Device Sequence Number: 4834773
• Product Code: GDC
• UDI-Device Identifier: 00885554023534
• UDI-Public: 00885554023534
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 11/06/2023
• 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